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The Role
Perform quality control testing of raw materials, finished products, stability samples, and microbiological parameters in a regulated pharmaceutical manufacturing plant. Operate and calibrate analytical instruments, conduct method and process validation testing, maintain compliant documentation, support audits and inspections, investigate OOS/OOT results, and coordinate with QA, production, and regulatory teams to support product release.
Summary Generated by Built In
Job Title: QC Executive – (RM / FG / Stability / AMV & PV / Microbiology)Location: Indore – Regulated Pharma Manufacturing PlantDepartment: Quality ControlReporting To: QC Manager / Head – Quality ControlJob Type: Full-Time | Executive LevelJob 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 AnalysisPerform 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 ComplianceMaintain 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 & CalibrationOperate and calibrate instruments like HPLC, GC, UV, IR, Dissolution Apparatus, FTIR, etc.
Ensure timely preventive maintenance and validation of QC instruments.
4. Cross-functional CoordinationCoordinate 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.
Skills Required
- B.Pharm, M.Pharm, or M.Sc. in Chemistry, Microbiology, or Pharmaceutical Sciences
- 2–5 years of relevant experience in a regulated pharmaceutical manufacturing environment
- Knowledge of cGMP, GLP, and ICH guidelines
- Hands-on experience with analytical instruments and microbiology techniques
- Strong documentation and data integrity practices
- Training or certification in data integrity, cGMP, QMS, or instrument handling
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The Company
What We Do
SAVA Healthcare Limited is an Indian pharmaceutical manufacturer headquartered in Pune, with a registered office in Surendranagar, Gujarat. The company develops and manufactures nasal sprays, drops, dry-powder inhalers, oral solids, and topical preparations. Its business includes international operations, contract manufacturing, companion- and farm-animal healthcare, and herbal products, supported by research, development, and innovation capabilities for domestic and global healthcare markets.
