We at Acme Generics Pvt. Ltd. urgently looking for Senior Manager Quality control with below description.
Department: Quality Control
Designation: Senior Manager (Head QC)
Experience = 14-18 Years
Location: Baddi
Job Description
1. To manage QMS activity like change control, Deviation, CAPA, OOS, OOT, Lab
events etc.
2. To Conduct Risk Assessment& SOP reviews; investigating& supporting in the grievances.
3. Responsible for Document & review Specification, SOPs, Review of Test Data Sheet, Analytical
Test Report & Masters.
4. Responsible for review of Method Validation Protocols & Method Validation Reports.
5. To Monitor the Review of calibration/Preventive maintenance schedule.
6. Responsibilities to Initiate for Procurement of impurity standard/reference standard,
chemicals/reagents, columns, Laboratory glasswares etc.
7. To Develop and implement Site Policies & Procedures (SOPs) to assure compliance with
regulatory requirements, and corporate policies
8. Responsibilities to Supervising deviation review and managing the CAPA review, approval and
implementation reviews
9. To Create goals, objectives and measures to drive continuous improvement of the QC operations
10. To ensure system and procedures are in place for the data integrity. Carryout frequent checks and
challenge tests to maintain compliance and consistency in data security, storage, archival,
verification & originality.
11. Responsible for leading root cause investigations.
12. Responsible for preparation of experiment plan during investigation.
13. Responsible for implementing the CAPA Parameters after investigation.
14. Responsibilities assign to check the effectiveness of CAPA.
15. To ensure Co-ordination for IQ, OQ, PQ and qualification plan of the instruments.
16. Responsible for Coordinate & present all relevant documents to external auditors and to ensure
that corrective measures are taken on any non-compliance finding.
17. To Review method transfer protocols & reports & stability protocols.
18. Responsible for rendering technical support to the Section in charges and managers.
19. To Review various submissions to General Export and other regulatory markets related to quality
control.
20. Responsible for review of data for integrity.
21. To review of Hold time study protocol & report.
22. Responsible for Review of comparison protocol & report of multimedia DRP & Dose dumping
between RLD & exhibit batches.
23. Responsibilities of supervising inspection of raw material which improved product quality.
24. To complete quality projects within time by proper planning & execution of planning.
25. To ensure the Implementation of several measures to identify deformities, malfunctions or other
abnormalities such as Periodic verification of instruments/Equipment / components / products.
Interested candidates can share their updated resume at career@acmeformulation.com
Reference: Pharma vacancy
