Executive – Pharmaceutical Manufacturing Documentation

About the role

The Executive will lead the design, preparation and review of critical manufacturing documentation for pharmaceutical products. This role supports scale‑up, exhibit, intended and commercial manufacturing activities, ensuring compliance with regulatory and quality standards.

Key responsibilities

• Develop and review Pas‑X BMRs, qualification and verification protocols, reports and manufacturing batch records (MFC).
• Prepare and assess experimental and scale‑up batch reports, compile batch data, and create test batch validation and process validation protocols.
• Initiate and review change controls, incidents, deviations, CAPA, IPOOS, OOS, OOT, OOE, market complaints and other QAMS activities.
• Execute SAP‑related tasks such as loading master data for semi‑finished goods, recipes and bill of materials.
• Prepare and review stability protocols for experimental, exhibit and commercial products.
• Draft QRMs, conduct nitrosamine risk assessments and respond to regulatory queries related to process development.
• Participate in self‑inspection audits as an auditee and address observations.

Required profile

• 5 to 8 years of experience in pharmaceutical manufacturing documentation or quality assurance.
• Graduation in Pharmacy with a Master’s degree in Pharmacy.
• Strong understanding of regulatory requirements and quality management systems.

Required skills

• SAP
• Pas‑X manufacturing system