IPQA - Mfg. & Packing

Company Name: Zydus Healthcare Limited Industry: Pharmaceuticals Website: <https://www.zyduslife.com/zyduslife/> Location: Sikkim Unit II Position: Officer / Executive Department: Quality Assurance (QA) Role: IPQA - Manufacturing & Packing Qualification: B.Pharm / M.Pharm Experience: 2 to 6 Years Job Summary Zydus Healthcare Limited is seeking dynamic and quality-focused professionals for the position of Officer / Executive - IPQA (Manufacturing & Packing) at its Sikkim Unit II . The incumbent will be responsible for ensuring compliance with cGMP requirements, performing in-process quality assurance activities during manufacturing and packing operations, and maintaining adherence to regulatory and quality standards. Key Responsibilities Perform line clearance activities before the start of manufacturing and packing operations. Monitor manufacturing and packing activities to ensure compliance with approved Batch Manufacturing Records (BMR) and Batch Packing Records (BPR). Conduct in-process checks and verification as per approved procedures and specifications. Review and verify dispensing, production, and packaging documentation. Ensure implementation of cGMP, GDP, SOPs, and data integrity practices across production areas. Monitor environmental conditions and compliance with hygiene and safety requirements. Perform online inspection and sampling activities during manufacturing and packaging processes. Investigate and report deviations, incidents, and non-conformances identified during operations. Support change control, CAPA, and risk assessment activities. Participate in batch release documentation review and reconciliation activities. Coordinate with Production, Quality Control, Warehouse, and Engineering departments for smooth operations. Participate in internal audits, self-inspections, and regulatory audit preparations. Ensure compliance with company quality systems and regulatory requirements. Required Skills & Competencies Sound knowledge of cGMP, GDP, and pharmaceutical quality systems. Experience in IPQA activities related to oral solid dosage forms and packing operations. Familiarity with regulatory requirements such as WHO, EU GMP, and PIC/S guidelines. Good documentation and investigation skills. Understanding of Batch Manufacturing Records (BMR) and Batch Packing Records (BPR). Strong analytical and problem-solving abilities. Effective communication and teamwork skills. Proficiency in MS Office applications.