Job Title: QC Executive – (RM / FG / Stability / AMV & PV / Microbiology)
Location: Indore – Regulated Pharma Manufacturing Plant
Department: Quality Control
Reporting To: QC Manager / Head – Quality Control
Job Type: Full-Time | Executive Level
Job Purpose:
To perform quality control testing and analysis of raw materials, finished products, stability samples, and microbiological parameters as per current Good Manufacturing Practices (cGMP), standard operating procedures (SOPs), pharmacopeial standards, and regulatory requirements to ensure product quality and compliance.
Key Responsibilities:
1. Testing and Analysis
Perform chemical and instrumental testing of Raw Materials (RM) and Finished Goods (FG) as per pharmacopeial and in-house specifications.
Conduct Stability Studies in line with ICH guidelines and maintain records of stability trends.
Execute Analytical Method Validations (AMV) and support Process Validation (PV) testing.
Carry out Microbiological analysis of samples, including environmental monitoring, water testing, and microbial limit tests.
2. Documentation and Compliance
Maintain accurate, complete, and timely documentation (analytical reports, logbooks, LIMS/ERP entries).
Ensure compliance with cGMP, GLP, and regulatory standards (USFDA, EU-GMP, WHO, etc.).
Participate in internal audits, external regulatory inspections, and implement CAPAs.
Prepare and review standard operating procedures (SOPs), specifications, and testing protocols.
3. Equipment Operation & Calibration
Operate and calibrate instruments like HPLC, GC, UV, IR, Dissolution Apparatus, FTIR, etc.
Ensure timely preventive maintenance and validation of QC instruments.
4. Cross-functional Coordination
Coordinate with Production, QA, Regulatory Affairs, and other relevant departments to resolve testing issues and support product release timelines.
Participate in investigations of OOS/OOT results, deviations, and change controls.
Key Skills & Competencies:
Sound knowledge of cGMP/GLP and ICH guidelines.
Hands-on experience with analytical instruments and microbiology techniques.
Strong documentation and data integrity practices.
Good communication and team collaboration skills.
Eye for detail and high level of integrity.
Educational Qualifications:
B.Pharm / M.Pharm / M.Sc. (Chemistry / Microbiology / Pharmaceutical Sciences)
Experience:
2–5 years of relevant experience in a regulated pharmaceutical manufacturing environment.
Preferred Certifications:
Training in Data Integrity, cGMP, QMS, or Instrument Handling is an advantage.
