1. Key Responsibilities & Key Result Areas (KRAs)

- Documentation & BMR Review: Review and verify Batch Manufacturing Records (BMR), Batch Packaging Records (BPR), and analytical test logs prior to batch release. Maintain master documents (SOPs, STPs, Specifications).
- Line Clearance & In-Process QA (IPQA): Perform line clearance checks before commencing production, extraction, concentration, drying, and packaging operations. Perform regular IPQA audits during manufacturing.
- Quality Management System (QMS): Handle Deviations, Non-Conformances (NC), Change Controls, and Corrective and Preventive Actions (CAPA) in coordination with production and QC departments.
- Validation & Calibration: Assist in equipment qualification (IQ/OQ/PQ), process validation, cleaning validation, and routine calibration tracking for plant equipment and laboratory instruments.
- Vendor & Raw Material Quality: Oversee sampling procedures for incoming botanical raw materials (herbs, crude botanical extracts, solvents, packaging materials) and ensure compliance with botanical identification standards.
- Audit & Regulatory Compliance: Assist during external customer audits, regulatory inspections (FSSAI, WHO-GMP, ISO, AYUSH), and internal periodic quality audits.
- Training & Hygiene Monitoring: Conduct cGMP, safety, and hygiene training sessions for plant personnel. Monitor plant sanitation, pest control,



and environmental conditions.

2. Key Performance Indicators (KPIs)

- 100% timely execution and closing of IPQA line clearance and BMR reviews.
- On-time closure of CAPAs, Deviations, and Market Complaints (within defined SLA).
- Zero critical compliance findings during internal and external quality audits.
- Adherence to annual validation schedules and SOP training timelines.

- Educational Qualification: B.Sc / M.Sc in Chemistry, Industrial Chemistry, Biotechnology.
- Experience: 2 to 5 years of hands-on QA experience in Phytochemicals, Herbal Extracts, Active Pharmaceutical Ingredients (API), or Nutraceutical manufacturing plants.
- Technical Knowledge: Strong understanding of solvent extraction processes, spray drying, cGMP guidelines, ISO 22000 / HACCP, FSSAI, and regulatory requirements for botanical extracts.

4. Key Skills & Competencies

- Strong documentation and technical writing skills (SOP creation, qualification protocols).
- High attention to detail and sound decision-making regarding batch release and line holds.
- Positive communication and interpersonal skills to liaise with Production, QC, and R&D; teams.
- Proficiency in MS Office and ERP system operations (SAP/Oracle/Custom ERP).

Pay: ₹200,000.00 - ₹400,000.00 per year

Work Location: In person

📌 QA Officer (Umargam)
🏢 SHREERAM JOB SERVICE-GUJARAT
📍 Umargam