906 Validation Specialist jobs in India

Validation Specialist

Hyderabad, Andhra Pradesh Elongo Global Solutions

Posted 5 days ago

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Job Description

About Us

Elongo is a growing and innovative organization delivering high-quality business support and talent solutions across diverse industries, including pharmaceuticals, life sciences, technology, and engineering .

We partner with global enterprises to provide specialized professionals and managed services that drive operational excellence and compliance.

As part of our continued growth, we are seeking an experienced and dynamic Validation Specialist to support our client’s pharmaceutical operations and global validation initiatives.


Location: Hyderabad (Hybrid: 3 Days Office / 2 Days Remote)

Engagement: 18-Month Contract-to-Hire


About the Role

The Validation Specialist will execute and support validation activities in alignment with global quality standards and regulatory requirements . The role requires solid expertise in Computer System Validation (CSV) , along with hands-on experience in Equipment/Utility Qualification and/or Process, Cleaning, and Method Validation .

The ideal candidate is detail-oriented, compliance-driven, and capable of independently managing validation deliverables across cross-functional teams.

Key Responsibilities
  • Execute validation protocols and reports for systems, equipment, and processes.
  • Conduct Installation, Operational, and Performance Qualification (IQ/OQ/PQ) activities.
  • Support risk assessments , gap analyses, and remediation planning.
  • Maintain documentation in accordance with cGMP, GAMP 5 , and company procedures.
  • Participate in audits, CAPA investigations , and deviation resolution.
  • Collaborate with cross-functional teams to ensure timely project completion.
  • Contribute to SOP development and updates as part of continuous improvement initiatives.
Core Expertise Areas
  • Computer System Validation (CSV) – Mandatory: Hands-on experience with validation of GxP systems (MES, LIMS, ERP, QMS).
  • Equipment/Utility Qualification: Strong understanding of qualification lifecycle, FAT/SAT , and change control.
  • Process/Cleaning/Method Validation: Preferably for oral solid, topical, or spray forms .
Profile Requirements
  • Bachelor’s or Master’s degree in Engineering, Pharmacy, or Life Sciences.
  • 8–10 years of experience in pharmaceutical validation.
  • Strong working knowledge of GAMP 5 , FDA , and EU regulatory guidelines .
  • Excellent documentation, analytical, and organizational skills.
  • Self-driven, detail-oriented, and able to work effectively in a global matrix environment .
What We Offer
  • Opportunity to work on international validation projects and systems .
  • Exposure to multi-site operations and diverse regulatory frameworks.
  • Hybrid work model offering flexibility and work-life balance.
  • Long-term engagement with growth and career advancement opportunities .
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Clin DB Validation Specialist

Kochi, Kerala IQVIA

Posted 2 days ago

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Job Description

Job Overview
Conduct testing activities in CDMS environment and provide comprehensive testing expertise to the team to produce efficient, quality database that meets customer requirements.
Essential Functions
- Independently conduct testing activities to validate edit checks, system settings, SAS listings, Transfer Programming and custom reports in platforms including, InForm, RAVE, OCRDC.
- Solid understanding of database structure.
- Ensure validation processes and best practice guidelines are being followed strictly by self and team.
- Solid understanding of documentation requirements and update all relevant documentation in a timely manner.
- Communicate status of project to Validation Team Lead/Manager.
- Escalate problems to the attention of Validation Team Lead/Manager.
- Mentor Associate Validation Analysts in all testing activities.
- Conduct Quality Reviews of testing projects on an ongoing basis as applicable.
- Provide suggestions for continues process improvement and actively participate and contribute towards process improvement initiatives as assigned.
- Understand and comply with core Operating Procedures and Work Instructions (including Best Practice and Guidance documents).
- Meet project objectives as assigned by Validation Team Lead/Manager.
- Develop and maintain good communications and working relationships with multiple teams across locations.
Qualifications
- Bachelor's Degree Bachelor in Science/Computer science/Information Technology or Bachelor in Technology Req
- 1 - 2 years of relevant clinical DB Testing experience in CDMS Platforms and total exp being 2+ yrs Req
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.
To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.
EEO Minorities/Females/Protected Veterans/Disabled
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Clin DB Validation Specialist

Bangalore, Karnataka IQVIA

Posted 2 days ago

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Job Description

Job Overview
Conduct testing activities in CDMS environment and provide comprehensive testing expertise to the team to produce efficient, quality database that meets customer requirements.
Essential Functions
- Independently conduct testing activities to validate edit checks, system settings, SAS listings, Transfer Programming and custom reports in platforms including, InForm, RAVE, OCRDC.
- Solid understanding of database structure.
- Ensure validation processes and best practice guidelines are being followed strictly by self and team.
- Solid understanding of documentation requirements and update all relevant documentation in a timely manner.
- Communicate status of project to Validation Team Lead/Manager.
- Escalate problems to the attention of Validation Team Lead/Manager.
- Mentor Associate Validation Analysts in all testing activities.
- Conduct Quality Reviews of testing projects on an ongoing basis as applicable.
- Provide suggestions for continues process improvement and actively participate and contribute towards process improvement initiatives as assigned.
- Understand and comply with core Operating Procedures and Work Instructions (including Best Practice and Guidance documents).
- Meet project objectives as assigned by Validation Team Lead/Manager.
- Develop and maintain good communications and working relationships with multiple teams across locations.
Qualifications
- Bachelor's Degree Bachelor in Science/Computer science/Information Technology or Bachelor in Technology Req
- 1 - 2 years of relevant clinical DB Testing experience in CDMS Platforms and total exp being 2+ yrs Req
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.
To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.
EEO Minorities/Females/Protected Veterans/Disabled
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Head - Process Validation

Navi Mumbai, Maharashtra Reliance Bio Energy

Posted 25 days ago

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Job Description

full-time

Looking for a Chartered Accountant/MBA Finance with 15-20 years of experience. Experience in energy, infrastructure, or manufacturing sectors with exposure to operational finance and familiarity with process audit frameworks and continuous improvement methodologies will be preferable.


The role will lead the financial and commercial validation of operational processes across the bio energy business, ensuring alignment with financial controls, cost efficiency, and commercial integrity. Drive process standardization and validation to support scalable and compliant growth


Key Responsibilities:

  1. Validate financial and commercial aspects of operational processes across production, logistics, and procurement
  2. Ensure process compliance with internal policies, accounting standards, and regulatory norms
  3. Collaborate with cross-functional teams to assess and improve process efficiency and cost-effectiveness
  4. Develop and implement validation frameworks for new and existing business processes
  5. Monitor key financial metrics and ensure accurate reporting of validated processes
  6. Support audits and ensure documentation readiness for all validated workflows
  7. Provide insights and recommendations for process improvements and risk mitigation 
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Quality Assurance ( Process Validation, Qualification )

Bavla, Gujarat Swiss Parenterals Ltd

Posted 5 days ago

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Department: Quality Assurance (Process Validation, Qualification )

Designation: Officer / Executive

Experience: 2 to 6 Years

Location: Bavla, Ahmedabad

Education: M. Pharma/ B. Pharma/ M. Sc


Job Description: ( Process Validation )


  1. To prepare standard operating procedure.
  2. Issuance of controlled Format to concern department.
  3. Provide the required documents to regulatory for dossier submission.
  4. Follow – up with concern department to complete the documentation.
  5. To prepare protocol for Process Validation, cleaning validation and hold time validation study.
  6. To execute process validation, hold time validation and cleaning validation activity and co-ordination with all departments for planning.
  7. Review of protocols for process validation, cleaning validation and hold time validation
  8. Preparation and communication of critical process parameters based on process validation study
  9. Preparation and communication of hold time to production based on obtained hold time study reports.
  10. Sample collection, submission, report compilation and preparation of summary report for process validation, cleaning validation and hold time validation.
  11. Issuance of Hold time Validation, cleaning validation and Process Validation Protocol.
  12. Any other work assigned by HOD.


Job Description: ( Qualification )


  1. Qualification of Equipment/system such as HVAC System, Autoclave, Bung Processor, Powder Filling and Sealing machine, Vial washing machine, Depyrogenation tunnel, Hot air oven, various Equipment.


  1. To prepare, review and execute protocol and report of validation for critical manufacturing processes like hold time, process validation, cleaning validation and media fill including observation of the media fill vials/ampoules etc.


  1. To Prepare, review and fill the IQ, OQ, PQ document of new Equipment/machine.
  2. Develop, Implement, manage, audit and maintain GMP Quality system.
  3. Review and approval of SOPs and other documentation related to the activities Participating in internal audits, for cause inspections etc.
  4. To review and check the QA SOPs and provide training before SOP implementation.
  5. To review another department SOPs.
  6. To review & approval of Master Documents like BMR, Protocols and Reports etc.
  7. Approve and release the final products or reject defectives.
  8. To Prepare SOPs, Protocol and Report related to all Qualification and Validation studies.
  9. Monitoring during calibration of various instruments.
  10. Follow the Qualification schedule to plan, execute and documentation.
  11. Performing the Temperature mapping activity of Manufacturing and staging area, Row Material storage area, Finished Goods area (NMT 25°C) and Cold Chamber (2°C to 8°C).
  12. To perform the new equipment/machine qualification (IQ/OQ/PQ).
  13. Prepared, review and filled the IQ, OQ, PQ document of new Equipment/machine.
  14. Review and approval of SOPs and other documentation related to the activities Participating in internal audits, for cause inspections etc.
  15. Understand customer needs and requirements to develop effective quality processes
  16. Responsible to maintain the plant hygiene.
  17. Vendor audit to the site for raw material and packing material supply, site evaluation, audit report preparation, vendor documents pack verification and final approval to include vendor in approved vendor list.



Must Exposure in Parenteral Background


We wish to have association with people like you in our organization and you may confirm your interest by sending your detailed Resume on

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Process Design & validation engineer

Pune, Maharashtra ACL Digital

Posted 5 days ago

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Job Description

Industrial /Mfg Engineering Degree - B.E

Exp-5+ Years (Less than 5 Yrs exp please do not apply )

Immediate to 30 days or Serving NP (can join in OCT Month)

Experienced in below activities:

MUST : Creo, Inventor, AutoCAD, FCAD, SAP,ENOVIA

Any process planning tool - Eg . MPM Link, DELMIA ,TECHNOMATICS etc )

1. Assembly process planning & Mfg & Assembly Line design

Experienced in generating PFMEA,Control Plans, Work Instructions & Factory Layout design

2.Good understanding of Design for Mfg & assembly concepts

3. Develop assembly routings & operator optimization for complete assembly of products

4. Establish routings ,methods,layouts ,tools ,costs,method documentation,quality plans & labor standards for revision to current operations.

5. Practicing Lean Mfg , Value stream Mapping, Facility Planning, Material management ,statistical data analysis

6. Experience in New Product development & VAVE

7. Experience in Tool & Fixture design

8. Experience in trouble shooting welding challenges would be an added advantage


L

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Quality Assurance

Surat, Gujarat 9Dot Technology

Posted 5 days ago

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Job Description

Job Description:

We are seeking a detail-oriented and proactive Quality Assurance (QA) Engineer to join our team. The ideal candidate will ensure that our web applications, mobile applications, and CRM systems meet the highest standards of quality, performance, and reliability. You’ll work closely with developers, business analysts, and project managers to identify issues early, track bugs, and guarantee smooth releases.

Key Responsibility:

  • Review business and technical requirements to ensure clarity and testability.
  • Develop, execute, and maintain detailed test plans, test cases, and test scripts.
  • Perform manual and automated testing for web, mobile, and CRM platforms.
  • Identify, document, and track defects using bug-tracking tools (e.g., JIRA, Trello).
  • Collaborate with the development team to reproduce, diagnose, and resolve issues.
  • Conduct regression, integration, functional, and UAT testing.
  • Verify fixes and perform final validation before product deployment.
  • Ensure quality standards are met before every release or go-live.
  • Contribute to process improvement by identifying testing gaps and suggesting optimizations.


Required Skills and Qualifications:

  • Proven experience in software testing or QA role (manual and/or automation).
  • Familiarity with QA tools and bug-tracking systems (e.g., JIRA, Bugzilla, TestRail).
  • Understanding of SDLC, STLC, and Agile methodologies.
  • Basic knowledge of SQL and APIs for backend testing.
  • Excellent attention to detail and problem-solving abilities.
  • Strong communication and documentation skills.
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Quality Assurance

Pune, Maharashtra hastree Technologies

Posted 23 days ago

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Job Description

hybrid,fixed-term-employment,contract-to-hire,contract

Job Opening: QA Automation Engineer

Experience: 5 to 8 years

Skills Required: Selenium, Playwright, Java

Location: Pune, Chennai, Coimbatore, Bangalore (Hybrid)

We are looking for experienced QA Automation Engineers proficient in Selenium, Playwright, and Java to join our dynamic team. If you are passionate about quality assurance and automation, wed love to hear from you!


join our exclusive WhatsApp Channel:

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Quality Assurance Specialist

Pune, Maharashtra UnitedHealth Group

Posted 2 days ago

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Job Description

Optum is a global organization that delivers care, aided by technology to help millions of people live healthier lives. The work you do with our team will directly improve health outcomes by connecting people with the care, pharmacy benefits, data and resources they need to feel their best. Here, you will find a culture guided by inclusion, talented peers, comprehensive benefits and career development opportunities. Come make an impact on the communities we serve as you help us advance health optimization on a global scale. Join us to start **Caring. Connecting. Growing together.**
**Primary Responsibilities:**
+ Be able to perform QA audits for multiple projects
+ Derive effective QA sampling & audit methodology for the projects assigned
+ Possess analytical skills to monitor & measure the quality trend in the coding projects
+ Perform root cause analysis, identify knowledge gaps, and conduct training to project team
+ Review scope document & guidelines for new clients before the start of the project and own pilot
+ project delivery to meet client SLA on quality
+ Review & customize standard coding guidelines as needed
+ Identify error trends on client feedback & improve client experience by continuous improvements
+ Conduct training sessions on audit protocols, the comment matrix, and best practices for prospective auditors
+ Be able to respond to the internal coding queries with proper rationale
+ Follow external and internal compliance standards
+ Comply with the terms and conditions of the employment contract, company policies and procedures, and any and all directives (such as, but not limited to, transfer and/or re-assignment to different work locations, change in teams and/or work shifts, policies in regards to flexibility of work benefits and/or work environment, alternative work arrangements, and other decisions that may arise due to the changing business environment). The Company may adopt, vary or rescind these policies and directives in its absolute discretion and without any limitation (implied or otherwise) on its ability to do so
**Required Qualifications:**
+ Educational Background: Degree in Life Sciences or Medical/Paramedical Sciences
+ Certifications: Valid AAPC or AHIMA certification is required
+ Experience: 3+ years of experience HCC Risk Adjustment Coding
+ Knowledge on risk adjustment models - Medicare & Commercial
+ Well-versed in coding standards and guidelines, including ICD-10-CM guidelines, AHA coding clinic updates, and client-specific guideline requirements
_At UnitedHealth Group, our mission is to help people live healthier lives and make the health system work better for everyone. We believe everyone-of every race, gender, sexuality, age, location and income-deserves the opportunity to live their healthiest life. Today, however, there are still far too many barriers to good health which are disproportionately experienced by people of color, historically marginalized groups and those with lower incomes. We are committed to mitigating our impact on the environment and enabling and delivering equitable care that addresses health disparities and improves health outcomes - an enterprise priority reflected in our mission._
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Quality Assurance Specialist

Chennai, Tamil Nadu UnitedHealth Group

Posted 2 days ago

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Job Description

Optum is a global organization that delivers care, aided by technology to help millions of people live healthier lives. The work you do with our team will directly improve health outcomes by connecting people with the care, pharmacy benefits, data and resources they need to feel their best. Here, you will find a culture guided by inclusion, talented peers, comprehensive benefits and career development opportunities. Come make an impact on the communities we serve as you help us advance health optimization on a global scale. Join us to start **Caring. Connecting. Growing together.**
**Primary Responsibilities:**
+ Be able to perform QA audits for multiple projects
+ Derive effective QA sampling & audit methodology for the projects assigned
+ Possess analytical skills to monitor & measure the quality trend in the coding projects
+ Perform root cause analysis, identify knowledge gaps, and conduct training to project team
+ Review scope document & guidelines for new clients before the start of the project and own pilot
+ project delivery to meet client SLA on quality
+ Review & customize standard coding guidelines as needed
+ Identify error trends on client feedback & improve client experience by continuous improvements
+ Conduct training sessions on audit protocols, the comment matrix, and best practices for prospective auditors
+ Be able to respond to the internal coding queries with proper rationale
+ Follow external and internal compliance standards
+ Comply with the terms and conditions of the employment contract, company policies and procedures, and any and all directives (such as, but not limited to, transfer and/or re-assignment to different work locations, change in teams and/or work shifts, policies in regards to flexibility of work benefits and/or work environment, alternative work arrangements, and other decisions that may arise due to the changing business environment). The Company may adopt, vary or rescind these policies and directives in its absolute discretion and without any limitation (implied or otherwise) on its ability to do so
**Required Qualifications:**
+ Educational Background: Degree in Life Sciences or Medical/Paramedical Sciences
+ Certifications: Valid AAPC or AHIMA certification is required
+ Experience: 3+ years of experience HCC Risk Adjustment Coding
+ Knowledge on risk adjustment models - Medicare & Commercial
+ Well-versed in coding standards and guidelines, including ICD-10-CM guidelines, AHA coding clinic updates, and client-specific guideline requirements
_At UnitedHealth Group, our mission is to help people live healthier lives and make the health system work better for everyone. We believe everyone-of every race, gender, sexuality, age, location and income-deserves the opportunity to live their healthiest life. Today, however, there are still far too many barriers to good health which are disproportionately experienced by people of color, historically marginalized groups and those with lower incomes. We are committed to mitigating our impact on the environment and enabling and delivering equitable care that addresses health disparities and improves health outcomes - an enterprise priority reflected in our mission._
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