Quality Assurance

1 day ago

Navsari, Gujarat, India Gufic Group Full time ₹ 8,00,000 - ₹ 12,00,000 per year

Roles and Responsibilities

  1. Responsible to design validation/ qualification strategies.
  2. Responsible for validation /qualification of processing equipment's, cleaning equipment's and testing equipment's on time.
  3. Responsible to review & approve of validation /qualification protocols and reports.
  4. Responsible for day to day validation planning and execution activity.
  5. Planning, Execution & Participation of aseptic process simulation activity.
  6. Responsible for process validations, hold time studies, thermal studies, transport validation, filter validation etc but not limited.
  7. Responsible to design, review, approve and implementation of departmental standard operating procedures.
  8. Responsible to review, approval and authorization of all standard operating procedure of the site.
  9. Responsible to approve specifications, standard test procedures and analytical work records.
  10. Responsible to approve master batch manufacturing records and master batch packing records.
  11. Responsible to integrate all the standard operating procedures and to design a quality system to prevent and correct quality related subjects.
  12. To approve quality management system documents i.e. change controls, deviations, incident reports, out of specifications, out of trends, non-conformance reports, market complaints, product recalls, returned goods, corrective and preventive action reports.
  13. To handle the market complaints and to participate in product recall.
  14. Responsible to perform vendor audit & approve vendor for raw materials, packing materials, contract manufacturing facilities & contract testing laboratories.
  15. Responsible to finalize annual GxP / Technical training planner as per requirement and Its Plan, execution as planner.
  16. Responsible to conduct internal audit /self-inspection to ensure compliance to cGMP and other regulatory requirements.
  17. Responsible for regulatory & customer audits preparation, execution and its compliance.
  18. Responsible to review of annual product quality review, environment monitoring trends & water systems testing trends.
  19. Responsible to co -orientate with internal as well as external department personnel to maintain the CGMP environment
  20. Responsible to update & maintain online departmental documentation.
  21. To ensure supply of products and service are having acceptable standards.
  22. To approve and authorize technical agreements from customer and outside party.
  23. To approve & authorize protocol received from outside party.
  24. Responsible to approve and authorize destruction of rejected materials/batches.
  25. Responsible to coordinate with regulatory department for submission of dossiers and documents to regulatory department.
  26. Responsible to make the management aware of any deviation/non-compliance or any other quality related issues during validation/ qualification & processing.
  27. Responsible to inform top management for future requirement of departmental up-gradation necessary for the growth of organization and to meet regulatory requirement.
  28. To ensure the implementation of quality risk management procedures.
  29. To ensure that proper implementation of data integrity policies.
  30. Responsible to approve SMF, VMP, quality manual and project validation documents & release the batch after the compliance with the specifications in absence of Senior Manager QA.

Desired Candidate Profile

Candidate Should have experience in Injectable plant only

Good Verbal & Written skill

Proficient in Ms office/Excel & Word

Perks and Benefits

Medical Reimbursement

Subsidized Accommodation for Bachelors

Professional Development

Paid time off

Work/life Balance

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