Position : Manager - Quality Assurance (Solid Orals)
Qualification : B.pharma/ M.pharmaExperience : 12-16 Yrs.
Job Location - Acme Generics, Baddi (H.P.)
Job Role & Desired Experience –
1. Responsible for Overall Quality Management System.
2. Responsible for Approval of general documents (but not limited to) Site Master File, Validation Master
Plan, Validation/Qualification Protocols/ Report & yearly calibration Calendars. PM Planners, BMR/ BPR, SOPs, APQR, IPQR, Specifications, Standard testing procedures, general testing procedures etc.
3. Responsible for review and approval of market complaint, change control through EQMS, OOS, OOT, product recall, mock recall and coordination of same with third party/ regularly for intimation/
notification/approval.
4. To form investigation team and monitor effective implementation of CAPA associated with incidents, OOS,
complaints, deviation, OOT recalls or any other quality element.
5. Responsible for compliance with technical or regulatory requirements related to the quality of finished
products and the approval of the release of finished product distribution and sale.
6. Responsible for inspection, investigation and taking of samples in order to monitor factors that may affect
product quality.
7. To ensure compliance of data integrity either manual data or electronic record.
8. Implementing and monitoring all Quality Assurance systems to ensure compliance with CGMP/regulatory
guidelines, develop progressive Quality Culture across the organization.
9. Developing and implementing the Quality departments strategy, to ensure it meets the business
requirements and customer deliverables, as well as enhancing the departmental performance.
10. Implementing and maintaining a Quality Risk Management system to ensure that risks are adequately
controlled and deliver a quality product as per CGMP.
11. Reviewing and approving Technical and Quality Agreements.
12. Work across all disciplines (e.g. manufacturing, packing, warehouse, engineering, QC, QA, RA, HR, R&D) to ensure the all-time readiness of plant for various GMP compliance audits.
13. Audit, Approval and monitoring of contract manufacturers, Supplier and outside Laboratories as per GMP
requirement.
14. Responsible to ensure that process validation, cleaning validation, equipment validation, Preventive maintenance, calibration etc. activities are being carried as per schedule.
15. Responsible to ensure self-inspection/internal audit is being performed as per schedule and its compliance.
16. Ensure that training & development program implemented as per respective SOPs.
17. Responsible for external audit and its compliance.
18. Responsible for ensure stability studies of products are being performed as per schedule.
19. Overall monitoring of new product introduction through technology transfer documents.
Interested candidates may share their updated CVs on career@acmeformulation.com or WA @ 9418155173 with Current CTC Details, Expectations and Notice Period.
