QA/QC Chemist

Location: Pen, Maharashtra

Employment Type: Full-Time

Experience: 4–6 Years

Industry:* Pharmaceutical / Medical Devices

Job Summary

We are looking for an experienced QA/QC Chemist to ensure the quality and compliance of raw materials, in-process materials, finished products, and packaging materials. The candidate will be responsible for quality checks, documentation, GMP compliance, and supporting quality investigations.

Key Responsibilities
- Conduct in-process quality checks during manufacturing and packaging.
- Ensure compliance with cGMP, GDP, SOPs, and applicable regulatory requirements.
- Perform and verify line clearance* before manufacturing and packing activities.
- Monitor production activities to ensure adherence to approved procedures.
- Review BMR, BPR, logbooks*, and other quality documentation.
- Verify equipment cleaning and line clearance records.
- Support *deviation, CAPA, change control, and risk management* activities.




- Maintain accurate quality records and support audits and regulatory inspections.

Qualification

B.Sc./M.Sc. in Chemistry, Analytical Chemistry, Pharmaceutical Chemistry, or a related science discipline.

Required Skills
- Strong knowledge of *GMP, GLP, GDP, and QMS
- Knowledge of pharmaceutical quality and regulatory requirements
- Experience in *deviation, CAPA, change control, validation, and qualification
- Strong documentation and report-writing skills
- Valuable analytical and problem-solving abilities
- Proficiency in *MS Office and electronic quality management systems

Preferred Experience

Experience in *pharmaceutical manufacturing, sterile manufacturing, medical devices, or dialysis consumables* is preferred. Exposure to *WHO-GMP, ISO 13485, CDSCO, USFDA, or EU-GMP* will be an advantage.

Pay: ₹25,000.00 - ₹30,000.00 per month

Benefits:
- Paid sick time
- Paid time off

Work Location: In person

📌 QA/QC Chemist (Pen)
🏢 Nextstep Consultancy Services
📍 Pen