Quality Assurance Executive @Taloja

Elementis; Navi Mumbai; On-site; INR 900,000 - 1,400,000; Full time

Job summary

Elementis in Navi Mumbai is seeking a Quality Assurance professional for the Taloja facility. You will ensure product quality and regulatory compliance by maintaining cGMP-compliant quality systems under the Quality Manager. Responsibilities include audits, document control, and handling customer complaints.

The role requires overseeing internal quality audits, FDA-type audits, and records retention, with willingness to perform other quality-related tasks as directed.

Qualifications

• Quality assurance experience in pharmaceutical or personal care products.
• Knowledge of cGMP and regulatory requirements.

Responsibilities

• Implement and control documents: SOPs, work orders, quality manual, test methods, JDE procedures.
• Manage customer complaints—log, assign investigations, communicate with customers, initiate CAPA as needed.

Job description

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 Good 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 corrective responses and follows up with the department that is responsible for completing the corrective action.

FDA Audits:

• Participate in the audit with the FDA auditor.
• Responsible for responding to any observations received.
• Responsible for addressing all document related concerns/questions.
• If required - ensure all documentation and follow-ups are completed.

Records Retention Coordinator for Taloja Facility:

• Communicates with managers to assure compliance.
• Contact person for compliance of records retention procedures.
• Maintains control of archived records onsite

Approves all intermediate and finished product work orders:

• Reviews intermediate product work orders
• Reviews finished product work orders
• Final approval on finished product prior to shipment
• JDE approval prior to product released for shipment

Advice Quality Manager and site Management on any critical findings or potential quality related issues.

Management of Change Coordinator (MOC):

• Responsible for document review of new and modified documents.
• Ensures the change is properly documented.
• Ensures the Department responsible for the change completes training and files proper paperwork with the final MOC paperwork. Final approval on all MOC\'s.

Others:

• Equipment Qualification and validation document review.
• Review of change control, deviation, CAPA, OOS, OOT, lab

Incidences.

• Preparation and review of Standard Operating Procedure.
• Raw Material Release
• Face customer/Regulatory audits and their compliance.

Willing to do any other quality related work assigned by the reporting manager and management.