Job Responsibilities


  1. Quality Assurance Compilation of Supporting documents for Change Control/Deviation/CAPA/OOS. 
  2. Responsible for Document Archival & up keeping.
  3. Preparation of Certificate of Analysis for Dispatch as per Sale order. 
  4. To work & implement the cGMP practices in to all departments as per SOPs. Preparation of SOPs & relative documents. 
  5. Document quality assurance activities with internal reporting and audit
  6. Develop new standards for production and design, with improvements as needed, and create testing protocols for implementation across all service lines
  7. Identify training needs and take action to ensure company-wide compliance
  8. Preparation of DMF/ QMS/ SOP/ Log books etc
  9. Inspect raw materials to ensure consistency and integrity
  10. Plan, Conduct and Manage Internal Audits and Customer Audits as per the plan in compliance with GLP, protocol, SOP's and applicable standard regulations
  11. Preparation of audit reports for the audits conducted and release the reports to concern HOD
  12. Preparation and review of SOP's, review of study protocol
  13. Access Suitability of responses to audit findings and negotiate suitable actions needed to resolve audit findings
  14. Review of deviations and find plans and follow-up and ensure for its implementation.
  15. Assist in preparation of the facility for client/sponsor audits and regulatory inspection
  16. Perform the reconciliation of Project and Non-project related documents and send or archival review the equipment calibration/validation records.
  17. Control of documents issuance, retrival, archival.
  18. Compiling of data for MIS as per schedule
  19. Allocation of batches as per customer purchase order over mail.
  20. Review of certificate of analysis for finished products.



Skills

  1. Strong written and verbal communication skills
  2. Strong analytical and problem solving skills
  3. Good computer skills
  4. Self-motivated and able to prioritize the work.


Pedigree


B.Pharm/M.Pharm with 1-3 years of relevant work experience


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