9,756 Test Cases jobs in India

Key Responsibilities:

● Assist in writing and executing manual test cases.

● Perform regression, smoke, and exploratory testing.

● Document test results and report bugs using tools like JIRA.

● Learn and assist in basic automation scripting.

● Collaborate with the QA team in daily Agile routines.

Requirements:

● Should have 3 years of experience as a QA

● Pursuing or completed B.Tech/MCA or a relevant qualification.

● Strong logical and analytical thinking.

● Basic understanding of software testing concepts.

● Familiarity with any programming/scripting language is a plus.

● Excellent communication skills and a willingness to learn.

Good to Have:

● Knowledge of tools like Postman, Selenium, or JIRA.

Job location: Ahmedabad

Experience Required- 1+ years of experience in QA (Clinical Research)

Role & responsibilities

A. Review Protocol and its attachments.

B. Conduct in-process and retrospective audit of clinical phase of the study to ensure compliance to protocol, SOPs and applicable regulatory requirements.

C. Review Clinical report to verify that the data reported in the report, accurately reflects the raw data and to ensure that the report is prepared in compliance with SOP, ICH E3 and applicable regulatory requirements.

D. Conduct system audits as per the system audit plan.

E. Conduct vendor pre-qualification and re-qualification audits as per the vendor audit plan.

F. Preparation, Review, distribution, maintenance, recall and destruction of QMS Documents (SOPs, Policies, WIs, Manuals, forms and Plans . )

G. Review and maintain calibration, validation and Mapping documents and Temperature data / OOS data (Eurotherm data )review.

H. Issuance of logbooks.

I. Review of deviations, event and change control procedures and provide number to respective document.

J. Provide Instrument IDs as per SOP.

K. To maintain/update study/System specific tracker/Index on on-going basis.

L. Assisting Team in charge in Regulatory/Sponsor Audit.

M. Maintain Master Signature Log.

About The Role  

1. Create and maintain Quality Assurance Plans for development projects based on ASPICE CL2 compliant QA Process

2. Execute QA activities based on QA Plans

3. Report status and progress of QA Plan execution of projects.

4. Recommend process improvements based on QA metrics and KPIs of projects.

5. Regularly meet with project stakeholders and ASD QA organization.

Skills:- 1. Creating QA Plans for projects

1. Finding non-conformances by reviewing work products and auditing processes execution

2. Identifying project risks

3. Communicating with project stakeholders

4. Understanding processes, templates, and methods

5. Using widely used application tools for documentation, task and issue tracking, configuration management, requirements management, presentation, reporting and communication.

About The Role - Grade Specific 

Focus on Electrical, Electronics and Semiconductor. Develops competency in own area of expertise. Shares expertise and provides guidance and support to others. Interprets clients needs. Completes own role independently or with minimum supervision. Identifies problems and relevant issues in straight forward situations and generates solutions. Contributes in teamwork and interacts with customers.

WE ARE HIRING

Department: QA-IPQA DS Activities

Note: Only for Biological Companies

Only Male candidates

Experience: 3 to 6 years

Qualification: MSC /M Pharmacy/B Pharmacy

Job Responsibilities:

• Line clearance and Monitoring of batches manufactured at multiple stages / Activities in Production DS
• Experience in Downstream process with respect to Handling of AKTA Chromatography Systems, Column Packing and unpacking, TFF system
• Review and monitoring of In-Process quality checks in manufacturing area

Additional Responsibilities:

Involvement in review of Deviations, CAPAs, Risk Assessments, Market Complaints and Product Recalls

Any job assigned by the head of the department and immediate supervisor

Preparation of APQR (Annual Product Quality Review) reports for all the commercial products

Other Duties:

Perform and monitor IPQA activities at shop floor level in each and every stage at.

NOTE : Interested candidates please attach your CV - or whatsapp venkat / Manasa

Quality assurance, Change management, Change control, APQR's, Media fill, Microbiology Compliance and Documents handling in software

The applicant if selected will take care of quality assurance of the sterile manufacturing company

Key Responsibilities:

 - Support implementation and maintenance of the Quality Management System (QMS)

in compliance with ISO 13485:2016, MDR 2017, and applicable medical device

regulations.

- Prepare, review, and control quality documents (SOPs, Work Instructions, Policies).

Conduct internal audits, CAPA management, and change control activities.

Monitor adherence to Good Documentation Practices (GDP) and Good Manufacturing Practices

Practices (GMP).

Assist in regulatory submissions and inspections (CDSCO, US FDA, SFDA, etc.).

Ensure training compliance and support cross-functional teams in QMS

implementation.

Prepare and issue quality reports, NCR documentation, and audit records.

Qualifications & Experience:

B.Sc./M.Sc. in Biotechnology, Microbiology, Life Sciences, or related discipline.

Minimum 1 year of experience in QA (medical device industry preferred).

Knowledge of ISO 13485, MDR 2017, GMP/GDP.

Strong documentation, communication, and analytical skills.

Key Skills:

Quality Management Systems (QMS)

Internal Auditing (ISO 13485)

Regulatory & compliance awareness (Medical Devices)

Documentation & reporting

Job Type: Full-time

Pay: ₹25, ₹30,000.00 per month

Benefits:

• Cell phone reimbursement
• Health insurance
• Provident Fund

Work Location: In person

Job Summary:

The Quality Assurance (QA) Associate plays a key role in ensuring that processes meet established standards of quality, safety, and compliance. This role involves reviewing documentation, conducting inspections, monitoring processes, and working closely with crossfunctional teams to maintain and improve quality standards.

Key Responsibilities:

Perform routine quality checks processes and documentation.

Assist in the development, implementation, and maintenance of QA policies and procedures.

Ensure compliance with internal quality standards.

Investigate non-conformities, deviations, and customer complaints; participate in root

cause analysis and CAPA (Corrective and Preventive Actions).

Review and maintain quality documentation including SOPs, validation protocols, etc.

Support internal and external audits by preparing documents and facilitating auditor

needs.

Maintain accurate and organized QA records and logs.

Provide QA support during process transition time.

Qualifications:

Bachelors degree.

2-3 years of experience in a QA role, preferably in (e.g., Insurance sector)

Working knowledge of quality systems, regulatory guidelines, and industry best practices.

Strong attention to detail and excellent organizational skills.

Effective communication and problem-solving skills.

Proficient in Microsoft Office Suite and quality management software/tools.

Company Overview

Madhu Instruments Pvt. Ltd.
is a leader in precision medical device manufacturing, committed to innovation, quality, and global regulatory compliance. With state-of-the-art facilities and a customer-centric approach, we develop and deliver cutting-edge diagnostic and therapeutic products that improve patient outcomes worldwide.

Senior Executive – Quality Assurance (Design File Compliance)

Department:
Quality Assurance

Reports To:
QA Manager

Collaborates With:
R&D | Regulatory Affairs | Manufacturing | Senior Leadership

Location:
Delhi

Objective

• Ensure the compliant compilation, documentation, and maintenance of Design History Files (DHF), Design Files, and Technical Documentation for medical devices. Adhere to ISO 13485:2016, FDA 21 CFR Part 820, and EU MDR 2017/745, guiding cross-functional teams to meet regulatory timelines and audit readiness.

Key Responsibilities

Design File Compliance

• Develop and maintain DHF/Design Files and Technical Documentation per:
• ISO 13485:2016 (Clause 7.3 – Design & Development)
• FDA 21 CFR Design Controls)
• EU MDR 2017/745 (Articles 10, 61, 83; Annexes II & III)
• Include device description, intended purpose, specifications, GSPR checklist, risk management (ISO 14971), verification/validation protocols, clinical evaluation reports, and PMS plans.
• Ensure full traceability between design inputs, outputs, risk controls, and regulatory requirements.

Cross-Functional Coordination

• Liaise with R&D, Regulatory Affairs, Manufacturing, and Clinical teams to gather and consolidate inputs.
• Align documentation with EU MDR Annex III (PMS Technical Documentation) and track actions for CE marking and FDA 510(k) submissions.

Timeline Management & Reporting

• Develop and monitor project timelines, integrating EU MDR milestones (e.g., PMS updates, CER revisions).
• Provide regular (weekly/monthly) updates on progress, compliance gaps, and risks to the QA Manager, R&D Manager, and Managing Director.

Regulatory Audit & Inspection Readiness

• Prepare DHF and Technical Documentation for Notified Body audits, FDA inspections, and internal audits.
• Address findings related to EU MDR compliance (clinical evaluation, PMS data, UDI traceability) and FDA observations.

Risk Management & Post-Market Surveillance

• Collaborate with Risk Management to ensure files reflect EU MDR Annex I (GSPR) and Annex III (PMS requirements).
• Support updates to risk management files and PMS reports post-market launch.

Qualifications

Education:

• Bachelor's degree in pharmacy (B. Pharma) or Biomedical Sciences or Diploma in Regulatory Affairs or M. Tech in Medical Devices

Experience:

• 3+ years in QA/RA within the medical device industry
• Hands-on experience with DHF/Technical Documentation under FDA 21 CFR 820 and EU MDR 2017/745
• Familiarity with Annex II/III requirements, clinical evaluation reports (CERs), PMS, and clinical evidence

Skills:

• Strong understanding of EU MDR Articles 10, 61, 83 and GSPR checklist implementation
• Expertise in cross-functional project management and timeline tracking

Preferred Attributes

• Certification in Regulatory Affairs (RAC) or Quality Auditing (CQA).
• Experience with UDI requirements under EU MDR and FDA.
• Knowledge of the EUDAMED database and technical documentation submissions.