05 Aug
|
Zydus Group
|
India
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 agile 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.
Job Snapshot
Updated Date
20-07-2026
Job ID
JOB10900
Division
SIKKIM QA II
Location
Zhl - Sikkim|zhl-sikkim Plt., Gangtok, Sikkim, India
Experience
2 - 6 Years
Employee Type
P-P8-Probationer-HO Executive
📌 IPQA - Mfg. & Packing (India)
🏢 Zydus Group
📍 India