66 Quality Assurance Specialist jobs in Bhubaneswar

• Leading the development, implementation, and continuous improvement of the Quality Management System (QMS).
• Overseeing and executing validation activities for manufacturing processes, equipment, and analytical methods.
• Conducting internal audits and supporting external regulatory inspections (e.g., FDA, EMA).
• Managing deviation investigations, root cause analysis, and CAPA (Corrective and Preventive Actions) implementation.
• Reviewing and approving batch records, validation protocols, and other critical quality documents.
• Ensuring compliance with cGMP, GDP, and other relevant pharmaceutical regulations.
• Providing quality oversight for product development, manufacturing, and release.
• Training and mentoring QA team members and other personnel on quality procedures and compliance requirements.
• Interfacing with cross-functional teams, including R&D, Manufacturing, and Regulatory Affairs.
• Staying current with evolving regulatory guidelines and industry best practices.

• Master's degree in Pharmacy, Chemistry, Biotechnology, or a related scientific discipline.
• A minimum of 8 years of progressive experience in pharmaceutical Quality Assurance or Quality Control.
• Extensive knowledge of cGMP, ICH guidelines, and regulatory submission requirements.
• Proven experience in developing and implementing QMS, performing audits, and managing deviations.
• Excellent analytical, problem-solving, and decision-making skills.
• Strong project management and organizational abilities.
• Exceptional written and verbal communication skills, with the ability to effectively communicate complex quality issues.
• Experience with electronic QMS (eQMS) software is highly desirable.
• Ability to work independently and collaboratively in a remote work environment.

• Develop, implement, and maintain Quality Management Systems (QMS) in compliance with regulatory standards.
• Conduct internal and external audits of manufacturing sites, contract manufacturers, and suppliers.
• Review and approve batch records, validation protocols, and other critical quality documents.
• Investigate deviations, out-of-specification (OOS) results, and customer complaints, implementing CAPAs.
• Participate in regulatory inspections and provide necessary documentation and support.
• Develop and deliver quality training programs to relevant personnel.
• Monitor and assess manufacturing processes for adherence to GMP and internal quality standards.
• Contribute to the risk assessment and management process for pharmaceutical products.
• Collaborate with cross-functional teams, including R&D, Manufacturing, and Regulatory Affairs, to ensure quality objectives are met.

• Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related scientific field.
• Minimum of 5 years of experience in pharmaceutical quality assurance or quality control.
• In-depth knowledge of GMP, GLP, and regulatory guidelines relevant to the pharmaceutical industry.
• Experience with auditing, deviation management, and CAPA implementation.
• Strong understanding of pharmaceutical manufacturing processes and analytical testing.
• Excellent written and verbal communication skills.
• Proficiency in quality management software and electronic document management systems.
• Ability to work independently and manage multiple projects in a remote setting.
• Strong analytical and problem-solving skills.

• Develop and implement comprehensive quality assurance plans and protocols.
• Conduct thorough inspections, tests, and audits of products and processes.
• Identify, document, and track defects, ensuring timely resolution.
• Analyze quality data to identify trends and areas for improvement.
• Collaborate with cross-functional teams to address quality concerns.
• Ensure compliance with industry standards and regulatory requirements.
• Develop and maintain quality documentation, including SOPs and reports.
• Train and mentor junior QA staff (as applicable in a remote setting).
• Propose and implement strategies for enhancing product quality and reliability.
• Monitor and evaluate the effectiveness of implemented quality systems.

• Bachelor's degree in a relevant field (e.g., Engineering, Science) or equivalent practical experience.
• Minimum of 5-7 years of experience in Quality Assurance or Quality Control.
• Proven experience with various QA methodologies and tools.
• Strong understanding of quality management systems (e.g., ISO 9001).
• Excellent analytical, problem-solving, and critical thinking skills.
• Exceptional attention to detail and accuracy.
• Proficiency in creating test plans, test cases, and defect reports.
• Strong communication and interpersonal skills, with the ability to collaborate effectively in a remote environment.
• Self-motivated and able to manage time and workload effectively.

• Develop, implement, and maintain robust Quality Management Systems (QMS) in compliance with cGMP, ICH, and other relevant regulatory guidelines.
• Oversee and participate in internal and external audits (regulatory inspections, vendor audits).
• Review and approve batch records, validation documents, and change control requests.
• Investigate deviations, Out-of-Specification (OOS) results, and customer complaints, implementing corrective and preventive actions (CAPAs).
• Ensure adherence to all applicable regulatory requirements and company policies.
• Prepare and maintain Standard Operating Procedures (SOPs), specifications, and other quality-related documentation.
• Participate in the qualification and validation of equipment, processes, and analytical methods.
• Train personnel on GMP requirements and quality system procedures.
• Monitor key quality metrics and report on the performance of the QMS.
• Collaborate with cross-functional teams, including R&D, manufacturing, and regulatory affairs, to ensure product quality and compliance.
• Stay abreast of evolving regulatory landscapes and industry best practices.
• Act as a primary point of contact for quality-related inquiries and inspections.

• Bachelor's or Master's degree in Pharmacy, Chemistry, Biotechnology, or a related life science field.
• Minimum of 6-10 years of progressive experience in pharmaceutical Quality Assurance or Quality Control.
• In-depth knowledge of cGMP, GDP, and relevant regulatory guidelines (e.g., FDA, EMA, CDSCO).
• Proven experience in developing and managing Quality Management Systems.
• Strong understanding of validation principles (process, cleaning, analytical method).
• Excellent analytical, problem-solving, and critical thinking skills.
• Meticulous attention to detail and strong documentation skills.
• Exceptional communication, interpersonal, and presentation skills.
• Ability to work independently, manage multiple projects, and meet deadlines in a remote setting.
• Experience with risk management principles is highly desirable.
• Familiarity with the pharmaceutical industry in **Bhubaneswar, Odisha** is a plus.

• Ensure compliance with all applicable regulatory requirements and industry standards (e.g., FDA, EMA, ICH).
• Review and approve batch records, validation protocols, and other critical quality documents.
• Conduct internal audits and assessments of manufacturing processes and quality systems.
• Investigate deviations, non-conformances, and customer complaints, implementing corrective and preventive actions (CAPA).
• Participate in external audits by regulatory agencies and customers.
• Develop, revise, and implement Standard Operating Procedures (SOPs) and quality policies.
• Contribute to the validation and qualification of equipment, processes, and systems.
• Monitor quality metrics and prepare reports on the status of quality systems.
• Provide training to personnel on quality assurance principles and procedures.
• Stay current with changes in regulatory guidelines and industry best practices.

• Bachelor's degree in Pharmacy, Chemistry, Biology, or a related science field; Master's degree preferred.
• Minimum of 7 years of experience in Quality Assurance within the pharmaceutical industry.
• In-depth knowledge of GMP, GLP, and regulatory requirements.
• Experience with auditing, deviation management, and CAPA systems.
• Strong analytical, problem-solving, and decision-making skills.
• Excellent written and verbal communication skills.
• Proficiency in quality management software and Microsoft Office Suite.
• Ability to work independently and manage multiple priorities in a remote environment.
• Detail-oriented with a strong commitment to accuracy.

• Develop, implement, and maintain food safety programs (HACCP, GMP, etc.).
• Conduct internal audits to ensure compliance with food safety and quality standards.
• Monitor and analyze quality control data, identifying trends and areas for improvement.
• Investigate customer complaints and non-conformance reports, implementing corrective and preventive actions (CAPA).
• Oversee product testing and laboratory analysis procedures.
• Train employees on food safety policies, procedures, and best practices.
• Liaise with regulatory agencies and external auditors.
• Review and approve product specifications and labeling requirements.
• Collaborate with R&D and production teams on new product development and process improvements.
• Maintain accurate records and documentation related to food safety and quality.
• Stay updated on evolving food safety regulations and industry best practices.
• Contribute to the continuous improvement of the Quality Management System.

• Bachelor's degree in Food Science, Microbiology, Chemistry, or a related field.
• 5-7 years of experience in food safety and quality assurance within the food manufacturing industry.
• In-depth knowledge of HACCP principles and implementation.
• Familiarity with GMP, ISO 22000, FSSC 22000, or similar food safety standards.
• Experience with internal auditing and corrective action processes.
• Strong analytical and problem-solving skills.
• Excellent communication, interpersonal, and training skills.
• Ability to work independently and as part of a cross-functional team.
• Proficiency in data analysis and report generation.
• Attention to detail and strong organizational skills.
• Relevant certifications (e.g., HACCP Manager, PCQI) are a plus.

Responsibilities:

• Monitor production processes
• Ensure compliance with quality standards
• Conduct regular inspections and tests
• Collaborate with cross-functional teams on improvement initiatives

Food allowance

Annual bonus

Provident fund

• Perform qualitative and quantitative analyses on raw materials, in-process samples, and finished products using various analytical techniques (e.g., HPLC, GC, UV-Vis spectroscopy, titrations).
• Ensure all testing is conducted in compliance with Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP).
• Validate analytical methods and instrumentation according to regulatory guidelines.
• Maintain accurate and detailed records of all laboratory tests, results, and observations.
• Prepare certificates of analysis (CoA) for raw materials and finished products.
• Calibrate and maintain laboratory equipment, ensuring optimal performance and accuracy.
• Investigate out-of-specification (OOS) results and deviations, identifying root causes and implementing corrective actions.
• Participate in internal and external audits of the quality control laboratory.
• Stay updated with the latest pharmacopeial standards (e.g., USP, BP, IP) and regulatory requirements.
• Assist in the development and improvement of quality control procedures and protocols.
• Collaborate with production, R&D, and regulatory affairs departments to address quality issues.
• Ensure proper handling and disposal of chemicals and hazardous materials.
• Contribute to a culture of continuous improvement within the quality department.

• Bachelor's or Master's degree in Chemistry, Pharmaceutical Chemistry, or a related field.
• Minimum of 3-5 years of experience in pharmaceutical quality control or analytical testing.
• Proficiency in using analytical instruments such as HPLC, GC, UV-Vis, FTIR, etc.
• Strong knowledge of pharmacopeial standards and regulatory guidelines (e.g., ICH, FDA, GMP).
• Excellent understanding of analytical chemistry principles.
• Meticulous attention to detail and accuracy in testing and record-keeping.
• Ability to work independently and as part of a team in a laboratory setting.
• Good problem-solving and critical-thinking skills.
• Strong written and verbal communication skills.
• Experience with laboratory information management systems (LIMS) is a plus.