Executive - QA

Position Summary

This role defines the complete handling and monitoring of IPQA activities, which includes management of in-process controls from start of dispensing tll the completion of dispatch of the product from the facility. The IPQA team member should have proficient knowledge of batch manufacturing and packing operation per the regulatory, excipact and ISO requirements. This role is will have extended responsibility in product release, registration and new product development and launches related to Quality responsibility.

Responsibilities will include:

1. To provide line clearance while executing operational activities for different departments like but not limited to – warehouse, liquid production, solid production, PR-03 area, packaging area, dispatch area etc.
2. To review and approve Label content while packaging operation.
3. To review all routine logbooks and records for all manufacturing and operational activities.
4. To review the packaging record and batch manufacturing records for their completeness and correctness.
5. To prepare and review process validation protocol and reports.
6. To issue and maintain batch manufacturing record documents.
7. To be responsible for batch release of finished products.
8. To be part of process approver and verifier as quality assurance representative for dispatch of goods from facility.
9. To document and manage the return goods and further operation activity.
10. To monitor and ensure the calibration and preventive maintenance activity completion and proper tagging for all the equipment and instrument utilized in batch manufacturing, packing, and handling activity.
11. To be part of SOP preparation and review for QA department and act as a reviewer for the SOP of cross functional department
12. Preparation and review of process validation protocol and reports.
13. Management of control sample for Pharma Finished products
14. Management of customer samples and handling of customer sample request
15. To be part of change control review process for all cross functional change control and part of investigation pertaining to and not limited to Deviation, Market complaint, nonconformance etc. where operations related investigation inputs and involvement needed

Required Experience & Knowledge

Education

B.Pharma/M.Pharma, Msc. Chemistry, Btech or Mtech with biotechnology or chemistry.

Experience

2-5 years of experience in Pharmaceutical, API or excipient regulated industries.

Competencies & Skillsets

Functional / Technical 

• Technical writing skills
• Document and data management skills  
• Investigation tools and RCA tools knowledge
• Audit handling and auditing skills
• Technical knowledge of API/Excipient/Pharma manufacturing and packaging

Behavioral

• Good communication skills
• People Skills
• Cross functional collaboration  

Supervisory Responsibilities

No