QC Chemist Job Description

Experience: 59 Years
Industry: API
Department: Quality Control (QC)
Employment Type: Full time

Job Summary

We are looking for an experienced QC Executive to manage and execute quality-control activities in compliance with GMP, GLP, pharmacopoeial standards, and regulatory requirements . The ideal candidate should have hands-on experience in analytical testing, documentation, investigation, and laboratory operations within a pharmaceutical environment.

Key Responsibilities

- Perform and review analysis of raw materials, in-process samples, finished products, stability samples, and packaging materials .
- Handle analytical instruments such as HPLC, GC, UV-Visible spectrophotometer, FTIR, dissolution, Karl Fischer, pH meter , etc.
- Ensure testing is performed according to approved SOPs, STPs, specifications, pharmacopoeial methods, and GMP requirements .
- Review analytical data, worksheets, chromatograms, and laboratory records for accuracy and completeness.
- Handle OOS, OOT, deviations, incidents, and laboratory investigations and support CAPA implementation.
- Perform/participate in method validation, method verification, analytical method transfer, and instrument qualification activities.
- Ensure proper handling, calibration, maintenance, and qualification of laboratory instruments.
- Maintain QC documentation including COA, logbooks, worksheets, SOPs, specifications, and test records .
- Support stability studies and ensure samples are tested within defined timelines.
- Ensure compliance with data integrity (ALCOA+) principles.
- Participate in internal, customer, and regulatory audits and provide required QC documentation.




- Coordinate with QA, Production, R&D;, Warehouse, and other cross-functional teams .
- Train junior QC personnel on analytical procedures, GMP, safety, and laboratory practices.
- Ensure laboratory safety, housekeeping, chemical handling, and waste-disposal requirements are followed.

Qualification

- M.Sc. / B.Sc. in Chemistry, Analytical Chemistry, Pharmaceutical Chemistry, or related discipline.
- 59 years of relevant experience in Pharmaceutical QC / Analytical Laboratory .
- Strong hands-on experience with HPLC and other analytical instruments .
- Good knowledge of ICH, IP, BP, USP, GMP, GLP, and data-integrity requirements .
- Experience in OOS/OOT investigation and deviation/CAPA handling preferred.
- Good documentation, communication, analytical, and problem-solving skills.

Key Skills

- HPLC / GC / UV / FTIR
- Analytical Method Validation & Transfer
- Stability Testing
- OOS / OOT Investigation
- GMP / GLP Compliance
- Data Integrity / ALCOA+
- SOP & Documentation
- Instrument Calibration & Qualification
- Audit Readiness
- Team Handling & Training

Preferred Profile

Candidates with experience in regulated pharmaceutical manufacturing environments and exposure to USFDA / EU / MHRA / WHO-GMP audits will be preferred.

Job Title: QC Chemist/ Senior QC Executive
Experience: 59 Years
Education: M.Sc./B.Sc. Chemistry or relevant qualification
Department: Quality Control
Location: Nakkapalli.

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

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