Executive - Qc (microbiology / Hplc / Amv)
- Rusan Pharma
- 5 - 8 years
- Kandla
- 4 days ago
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Job Description
Open Positions:
- QC - Executive - AMV (Analytical Method Validation)
- QC - Executive - (HPLC)
- QC - Executive - Microbiology
Role Summary (For Executive AMV):
Responsible for execution of analytical method validation/verification activities as per ICH guidelines and ensuring compliance with regulatory standards.
Key Responsibilities:
- Perform method validation / verification / transfer as per ICH Q2(R1)guidelines
- Validate analytical methods for:
- Assay
- Related substances
- Dissolution
- Content uniformity
- Prepare and execute:
- Validation protocols and reports
- Conduct forced degradation / stability-indicating studies
- Perform system suitability and method precision studies
- Calibration and qualification of analytical instruments
- Maintain complete documentation as per GMP / GLP / Data Integrity
- Support audit readiness and regulatory inspections
Qualification & Experience:
- Education: M.Sc / B.Pharm / M.Pharm
- Experience: 4 - 5 years in AMV / method validation
Role Summary (Executive QC (HPLC)):
Responsible for routine and stability analysis using HPLC and other analytical instruments.
Key Responsibilities:
- Perform analysis of:
- Raw materials
- In-process samples
- Finished products
- Stability samples
- Operate instruments:
- HPLC, UV, Dissolution apparatus, GC (basic exposure preferred)
- Ensure:
- System suitability compliance
- Calibration and maintenance of instruments
- Prepare and maintain:
- Analytical reports
- Logbooks and worksheets
- Follow SOPs, STPs, and GMP/GLP requirements
- Handle OOS / OOT investigations
- Support method transfer and validation activities
Qualification & Experience:
- Education: B.Sc / M.Sc (Chemistry) / B.Pharm
- Experience: 4 - 5 years in HPLC analysis
Role Summary (Executive QC Microbiology):
Responsible for microbiological testing, environmental monitoring, and compliance activities in the plant.
Key Responsibilities:
- Perform:
- Microbial Limit Test (MLT)
- Bioburden testing
- Sterility testing (if applicable)
- Conduct Environmental Monitoring (EM):
- Air, surface, and personnel monitoring
- Handle:
- Media preparation and Growth Promotion Testing (GPT)
- Maintain:
- Culture handling and documentation
- Support:
- Water testing (PW/WFI)
- QMS activities (OOS, deviations, CAPA)
- Ensure compliance with GMP / GLP / aseptic practices
Qualification & Experience:
- Education: B.Sc / M.Sc Microbiology / Life Sciences / B.Pharm
- Experience: 4 - 5 years in QC Microbiology
Key Skills (Applicable to All Roles):
- Knowledge of GMP, GLP, and Data Integrity (ALCOA+)
- Good documentation practices
- Understanding of regulatory requirements (USFDA / EU basic awareness)
- Analytical and problem-solving skills
- Ability to work in shifts (if required)
Key Performance Indicators (KPI):
- Timely completion of analysis / validation activities
- Right First Time (RFT) documentation
- Compliance with SOPs and audit readiness
- OOS / deviation closure within timelines
- Instrument uptime and proper usage
Preferred Industry Exposure:
- USFDA / EU approved plants
- OSD / Injectable / Topical manufacturing units
Job Classification
Industry: Pharmaceutical & Life SciencesFunctional Area / Department: Quality AssuranceRole Category: Production & ManufacturingRole: QA / QC ExecutiveEmployement Type: Full timeContact Details:
Company: Rusan PharmaLocation(s): Kandla
Keyskills: Microbiology Formulation AMV HPLC Quality Control Qc Analysis QC QC Dept Analytical Method Validation
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Rusan Pharma
Rusan is a research driven pharmaceutical company having its Manufacturing Units in India and Worldwide Marketing of Pharmaceutical Formulation, Active Pharmaceutical Ingredients and Intermediates. The company has its Corporate office at Kandivli (west), Mumbai, state of the art, Bulk Manufacturing ...
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