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.

• Experience: 2+ years
• Seniority: Entry Level
• Education: Bachelor's degree required
• Languages: English