QA Specialist (Pharma MNC/office hours) #HCL

QA Specialist (Pharma MNC/office hours) #HCL

Responsibilities:

• Revise and review Standard Operating Procedures (SOPs) to ensure compliance and quality standards.
• Review executed Manufacturing Batch Records (MBR) / Equipment Batch Records (EBR) for completeness and accuracy.
• Provide quality oversight and support to the manufacturing team, addressing any quality-related queries, concerns, or issues.
• Participate in GMP (Good Manufacturing Practices) and GEMBA walks to ensure adherence to quality standards on the shop floor.
• Provide quality support for Change Control processes, ensuring compliance with quality standards.
• Manage and review deviations, ensuring thorough investigations and timely closure.

Requirements:

• Minimum of 2 years of experience in the pharmaceutical or biopharma industry (preferred), including experience in batch record review, SOP revisions, or quality assurance oversight.
• Experience in GMP and operational oversight activities (e.g., GEMBA, GMP walks) is advantageous.