
Position : AGM - Production Injectables.
Experience : 14 to 18 years.
Designation : Assistant General Manager
Qualification : M. Pharmacy/Pharmacy
Experience from sterile formulation industry (Injectable)
No.of Vacancies : 1
Job Description:
1. Responsible to ensure all the activity in manufacturing area of lines.
2. Approval of Indented Raw Materials, Primary Packaging Materials as per the production plan.
3. Coordination with cross functional team in the batch planning and ensure the Process flow, Personnel flow; Material flow shall be done as per the procedures.
4.To ensure compliance to the validation schedules - qualification, requalification of area, equipment, and facility.
5. To Ensure Prior intimation to validation team regarding any qualification, requalification of area, equipment, and facility.
6. Initiation, review, and timely closure of all QMS elements like Change control, PNC, Exceptions and CAPA as per procedure.
7. Attending trainings like on job, cGMP, External and Giving training on process related SOPs.
8. Updating cGMP related practices and recent regulatory up gradation to the personnel working in the shop floor to improve the systems.
9. Co-ordination with training team and ensures the completion of training of all the production personnel working in respective areas.
10. Following safety systems and GMP systems during the work execution.
11. To ensure the compliance of all the observation of internal audits.
12. Responsible for final review of in-process and Finished product batches
13. To ensure air flow visualization study (smoke study) as per approved protocol/sop.
14. Review and approval of CPV Monitoring Plan
15.Responsible for guiding visitors and auditors for Plant visit/Audit.
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