20 Aug
|
Nextstep Consultancy Services
|
Pune
20 Aug
Nextstep Consultancy Services
Pune
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
Solid 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
Advantages:
Paid sick time
Paid time off
Work Location: In person
📌 Qa/qc Chemist Pen (Pune)
🏢 Nextstep Consultancy Services
📍 Pune