Junior Associate, Quality Assurance (Open for Fresh Graduates)

Key Responsibilities

Quality Assurance Operations

• Perform routine In-Process Quality Assurance (IPQA) activities, including line clearance, in-process checks, and production area monitoring.
• Conduct online review of Drug Substance batch records and monitor manufacturing activities to ensure compliance with approved procedures and GMP requirements.
• Ensure adherence to cGMP, data integrity, and quality compliance standards across all assigned areas.

Documentation & Document Control

• Prepare, review, and maintain Quality Assurance Standard Operating Procedures (SOPs).
• Participate in peer reviews of SOPs and coordinate cross-functional review meetings.
• Issue, control, archive, and maintain master documents and obsolete documents in accordance with document control procedures.
• Manage issuance of annexures and GMP-related documentation.
• Ensure proper handling, retention, and destruction of GMP and scrap documents.
• Maintain employee specimen signature records and related documentation.

Investigations, Deviations & CAPA

• Initiate and manage Change Controls, Deviations, and Corrective and Preventive Actions (CAPA) related to Quality Assurance.
• Participate in investigations involving quality and production-related events and ensure effective implementation of CAPAs.
• Follow up on investigation outcomes and monitor action effectiveness.

Audits & Compliance

• Conduct cGMP audits, prepare audit reports, and track CAPA implementation.
• Support internal, customer, partner, and regulatory audits and inspections.
• Ensure compliance within QA office and document archival areas, identifying and reporting non-conformities.
• Promote and maintain compliance with company quality systems and regulatory requirements.