Officer - Quality Assurance

Role overview

This position focuses on quality assurance activities within a pharmaceutical manufacturing environment in Sikkim. The role is centered on maintaining compliance with SOPs, cGMP standards, validation practices, and site EHS requirements across manufacturing and packing operations.

Core quality assurance duties

• Monitor shop-floor adherence to SOPs and cGMP expectations.
• Carry out in-process checks at multiple stages of manufacturing and packing during validation activities, and confirm compliance.
• Conduct sampling across different stages of manufacturing and packing.
• Prepare, execute, and compile process validation work, including process performance qualification, cleaning validation, and cleaning verification.
• Take active part in qualification and calibration activities.
• Review master batch manufacturing records and batch packing records in SAP.
• Participate in investigations linked to product or system failures.
• Prepare APQR and validation/qualification protocols.
• Link BMR, BPR, and TDS data and record results in SAP.
• Ensure SOP and cGMP compliance during qualification and validation work.

Safety, environment, and compliance

• Follow the site’s EHS management systems.
• Observe all EHS rules, procedures, guidelines, policies, practices, requirements, and applicable legal obligations.
• Perform assigned tasks in a safe manner at all times.
• Maintain effective controls for high-risk activities and significant environmental aspects and impacts.

Experience and education

The role requires 3 years of work experience and a graduation degree in Pharmacy.

Additional notes

The source content does not specify vacancies, compensation, joining date, or application deadline.