Urgent Requirement For Production Documentation - Formulations

Job Title: Documentation Associate Production OSD - Formulations

Position Summary:
This role is responsible for managing and reviewing all production-related documentation to ensure compliance with GMP standards supporting to our formulations plant in the USA. Key responsibilities include preparing and reviewing qualification protocols, process validation reports, batch records, and managing deviations.

Education:
Bachelor's / Master's degree in Pharmacy or Chemistry.

Experience:
2 to 5 years of experience in production documentation.

Key Responsibilities:

• Prepare and review qualification protocols, summary reports, and monitor equipment qualifications.
• Prepare and review Batch Manufacturing Records (BMR) and Batch Packing Records (BPR) in compliance with SOPs.
• Prepare and review process optimization protocols, reports, and process validation protocols.
• Monitor the progress of optimization batches, validation batches, and commercial batches.
• Guide, review, and authorize deviation reports, incident reports, CAPA (Corrective and Preventive Actions), change control, and other GMP-compliant documents.
• Implement suggestions and changes provided by Research & Development (R&D).
• Monitor and record yield, and reconcile Batch Manufacturing and Packing Records.
• Address review comments and ensure compliance with feedback from QA, RA, auditors, and customers.
• Raise and close Temporary Change Controls, deviations, incidents, and CAPAs as required.

Key Skills:

• Strong understanding of GMP documentation.
• Excellent communication and collaboration skills.

Note: Shift Timings - 2pm to 10pm