Position Summary

Responsible for Quality Assurance for API and Personal Care products at Taloja facility under general direction of the Quality Manager. Assures consistent product quality and regulatory compliance by maintaining quality systems and current Positive Manufacturing Practices (cGMP); participating in audits (internal, vendor, customer, regulatory); providing proper document control; overseeing customer complaints.

Responsibilities

Document Control - Responsible for implementation and control over the following documents:
- Standard Operating Procedures for Production, Quality, Warehouse, Engineering, HR, Purchase, Supply Chain.
- Work Orders
- Quality Manual
- Test Methods
- JDE Procedures

Customer Complaints:
- Enters the complaint details in log.
- Determines who the responsible people are to be included in the complaint investigation Maintains the complaint file
- Contact with the customer via e-mail or phone calls
- Completes the complaint summary that is released to the customer, If required, Corrective and Preventative Actions initiated and maintained.




- Perform an annual report of all quality complaints.

Annual Product Review:
- Conducts a review of the previous year's production records.
- Completes and maintains the Annual Product Review file which includes....

a. A review of square root of X + 1 work orders for all products

b. SQC charting of the USP critical parameters for all lots produced.

Lead on Internal Quality Audits:
- Responsible for setting up meetings and putting together a Quality Audit Team to perform the annual internal audit of Taloja Facility.
- Responsible for setting up meetings regarding Internal Quality Audit Responsible for setting up the Quality Audit Team.
- Prepares the Audit Report
- Ensures that the corrective actions are addressed.

Customer Quality Audits:
- Schedules third party audits.
- After audits are conducted responsible for maintaining audit file.
- If corrective actions are required - manages the correc

📌 Quality Assurance Executive @Taloja (Navi Mumbai)
🏢 Elementis
📍 Navi Mumbai