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Position : QA Head

Qualification TongueG

Experience :8-12 years


Job Description : Accountable for providing accurate and independent assessment of quality standards, applying all regulations that govern product related operational activities Scheduling audit plans and coordinating with auditors Responsible for approving all the documentation as a final authority ensuring the implementation of GDP regulations Responsible in coordination with outside clients for the preparation of pre-work schedules, documentation and other project related activities. Accountable for analyzing and addressing the non-compliance issues Responsible for review and approval of all Quality Master documents (SMF,VMP.QMS, MFRs, BPRs, Equipment Qualification Reports, Internal Audit Reports, Management Review Meeting reports , Investigation Reports for Market complaints, APRs, Deviation report, Change control requests, Audit compliance reports) Responsible for identifying all quality related issues, providing solutions to resolve the issues in consultation with relevant departmental staff Accountable for review and final approval of SOP’s, protocols, CAPA documents, COA’s, validation reports and other quality documents Conduct cGMP trainings to improve GMP standards.

Designation : Assistant Manager - Sterile injectable

Qualification : UG/PG

Experience : 3 - 7 yrs.


Supervising the production activities and ensuring the compliance with the planned schedule.

Addressing the process issues and coordinating interdepartmentally for trouble free operations.

Verify any deviations and discrepancies in the batch stages and discuss with QA pesonnel to address the issue.

Coordinate with maintenance team and minimize downtime of the equipment.
Actively participate in the internal and external audits and work towards the compliance to GMP's.

Provide training on batch manufacturing,cGMP and SOP's to the executives.

Review of SOP's as per cGMP in coordination with QA personnel.

Process improvement to reduce cost of production through change control as per cGMP in coordination with QA.

Review qualifications and validation related to equipment, facility and process.

Review and finalize Master formula records for the products.

To keep track of consumables for production activities and maintain stock of consumables.

Co-ordination of any modification or renovation works to meet the customer demands or cGMP.

Review the batch records for completeness and correctness of information.