PHARMA JOB AND LEARNING - Bhagwan Das Vaishnav
Job opening - Manager / Sr. Manager - Quality Assurance @ Acme Generics, Baddi
Exp. 10-15 yrs
Qualification:- B. pharma/ M.Pharma
Job opening - Manager / Sr. Manager - Quality Assurance @ Acme Generics, Baddi
Exp. 10-15 yrs
Qualification:- B. pharma/ M.Pharma
Job Description
Followings will be the responsibilities of the position holder:
1. Responsible to ensure cGMP compliance in the departments.
3. Responsible for communication with clients for sending and receiving of compliance report/observation.
4. Responsible for preparation, scheduling & conducting self-inspection audits & compilation of reports.
5. Responsible for water system validation, HVAC, compressed air, facility validation.
6. Responsible to impart training on departmental SOPs, Good Manufacturing Practice (GMP) and Good documentation practice (GDP).
7. Responsible to review of process validation protocol & report and ensure effective execution of process validation activities.
8. Responsible for review of Hold time protocol & report and ensure execution of Hold time activities.
9. Responsible to review and authorization of Standard Operating Procedure of all departments.
10. Ensure the Qualification and Re- qualification of the Equipment, facility and system.
11. Ensure work discipline in the department.
12. Responsible for quality agreement and its compliance.
13. Responsible for review of all apex documents.
14. Responsible for Liasoning related documents like product approval, COPP, Free sale certificate, Renewal of manufacturing license and GMP Certificates etc.
15. Participate in review and investigation of Market Complaints.
16. Responsible for review of work related to Quality Management System.
17. Responsible for training compliance across the site.
18. Responsible for Coordination with clients for Technology Transfer.
19. Responsible for Coordination with different departments/Sites for submission of required documentation to different clients in timely manner.
20. Responsible for review and approval of Stability protocol and report.
21. Approval of BMR/BPR process certification protocol/report, shade card, Artwork, Stability Study protocol/report, test data sheet.
22. Approval of standard operating procedure, Standard testing procedure, general testing procedure, Qualification protocols/reports, Validation master plan (VMP), Site Master File, Quality Manual, Cleaning Validation and process validation protocol/report and deviation.
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