Note: We are looking for Quality Control Head to manage one of the API unit. Those who are already in similar position are eligible to apply Client : Leading pharma company Role : Quality Control Head (API Unit) Location: Vishkhapatnam/Vizag Qualification : Bachelor /Master of Pharmacy or Chemical Engineering or Masters in Organic Chemistry /Ph. D Experience: 15-20+ years of experience in Pharmaceutical industry (API) in leading Quality Control Operations. CTC : 38-40 LPA (all inclusive) Candidate should be stable in companies. Frequent job changes will not be entertained Mandatory skills: - Experience in leading Regulatory Inspections (e.g. FDA, EU) is a must. - Strong Knowledge of GMPs (ICH Q7, 21 CFR 210/211,) and other regulatory guidelines like ICHQ1-Q4, QMS, etc. - Proficient in all Quality related software's. - Strong leadership and interpersonal skills - Excellent written and verbal communication skills. - Transparent and ethical in dealing with difficult situations. To develop and deploy Quality Control Systems in QC Laboratory in line with regulatory requirement while enabling smooth plant operations. Responsibilities: 1. Ensuring the good documentation & good laboratory practices in the laboratory. 2. To attend the CGMP/technical/SOP training sessions. 3. Monitoring of wet analysis, stability study HPLC, GC, working standards qualifications. 4. Responsible for procurement of Reference standards, Evaluation & Maintenance of Standards management. 5. Handling of QMS related activities (Change controls, Incidents, Deviations, OOT, OOS and Investigation reports) and ensures the CAPA implementations. 6. Preparation and review of SOP's, STP's, Work sheets and Certificate of Analysis. 7. Review of Analytical documents followed as per cGMP, 21 CFR and Quality policy's 8. To ensure and conduct the Analytical Method validations/ Method Transfers/Method Verifications where ever required. 9. Preparation of study reports, Impurity profiles protocols & Reports. 10. Handling of Pharmacopoeia evaluations and supporting to Regulatory on DMF filings. 11. Handling of Regulatory and customer complaints & deficiencies. 12. Preparation of Technical reports for analytical evolutions & Customer complaints. 13. Responsible to check the Audit trials and electronic data management. 14. Ensuring and initiate the good documentation practices in the Quality Control Laboratory. 15. Audit preparations (Training and ensure the safety practices in quality control) 16. To ensure and review the Empower data management and relevant back-up procedure 17. To review the specification and Method of analysis before approval. 18. To ensure the preventive maintenance and calibration of stability chambers 19. To prepare & review the protocol as well as Reports pertaining to any technical data. 20. To review the analytical documents generated for DMF submission & Regulatory Queries. 21. To comply safety & GMP at work place. 22. Responsible for conducting the external audits as per the defined procedure. 23. Ensure that all return goods and recall being handled inline to the procedure. 24. Ensure trainings are conducted as per SOP & giving trainings to personnel as per plan. 25. Ensure SOP's shall be updated based on the current updating /Regulatory/Customer requirement as per defined procedures. 26. To performing any other assignment delegated from time to time. Those interested contact Manisha 9873002499

Vishakhapatnam/Vizag

Head - Quality Control - Pharma - API Site Unit 

Job Description for Head - Quality Control - Pharma - API Site Unit  in ABP Management Services in  Vishakhapatnam/Vizag for (15-24) years of experience. Apply Now!