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Senior Quality Assurance Specialist

2 weeks ago

Jaipur, Rajasthan, India beBeeQuality Full time ₹ 20,00,000 - ₹ 25,00,000
Job Title: Quality Assurance Expert

We are seeking an experienced Quality Assurance expert to join our team.

  • About the Job:

  • This is a challenging and rewarding role for someone who is passionate about quality and compliance. The successful candidate will be responsible for ensuring that all aspects of our business meet regulatory requirements and industry best practices.

  • Key Responsibilities:

  • The following tasks form part of this role:

    1. Develop, implement, and maintain quality audit systems and procedures to ensure compliance with regulations.

    2. Coordinate vendor qualification activities, including assessments, audits, and qualifications.

    3. Manage CAPA close-out processes for all audits and inspections.

    4. Develop, maintain, and improve document control systems to ensure compliance with GMP requirements.

    5. Establish robust Quality Management Systems (QMS) to manage change management, deviations, incidents, complaint handling, and CAPA management.

    6. Responsible for All GMP trainings and Quality training program

    7. Oversee investigations of all non-conformances (deviations, complaints, etc.).

    8. Responsible for handling product recalls.

    9. Create and maintain systems to implement ICH Q8, Q9, and Q10 requirements.

    10. Ensure cGMP requirements and quality standards are recognized, understood, and maintained across the company.

    11. Develop batch release and reject systems to ensure quality products are released to the market.

    12. Work across all disciplines to ensure the company maintains a state of readiness for inspection by regulatory agencies.

    13. Keep abreast of changes to quality regulations and guidelines, advising the management team on any business implications.

    14. Lead, manage, and ensure proper training for relevant change management programs.

    15. Provide quality guidance to product development projects and programs.

    16. Responsible for Data Integrity Internal Audits, Training, and Review, and Reporting to management.

    17. Ensure validation activities are carried out according to approved protocols and requirements.

    18. Well-versed in injectable product requirements, facility needs, and media fill requirements.

    19. Responsible for Technology Transfer documents, compiling necessary records, and smooth transmission to meet regulatory requirements.

    20. Maintain and improve departmental operational performance, meeting regulatory authority, company SOPs, external, and internal customer requirements for quality, service, lead time, and cost.

    21. Develop, implement, maintain, and improve Quality audit, maintain GMP quality systems and Behavioural GMP aspects