54 Job openings found

Vacancy: 01 Location: VAPI- GUJARAT Experience: 8 to 13 Years Qualification: B. Sc/ M. Sc- Micro/ Biotechnology with FDA Approval (Preference) Job Description: The ideal candidate will possess strong technical expertise in analytical instrumentation, regulatory compliance, and quality systems, with hands-on experience in RM, PM, and FG analysis. Key Responsibilities ...

Key Responsibilities Method Validation & Development Perform method validation as per ICH Q2 (R1/R2) guidelines Develop, optimize, and validate analytical methods for assay, impurities, dissolution, and residual solvents Conduct method verification and method transfer activities Prepare and review validation protocols and reports Instrumentation & Analysis Operate and maintain HPLC, UPLC, GC, and related detectors (UV, PDA, FID, ...

Supervise day-to-day QC laboratory activities (chemical, instrumental, and microbiology where applicable). Review and approve analytical results, COAs, test reports, and raw data. Ensure compliance with cGMP, GLP, ICH, and regulatory guidelines (USFDA, EMA, WHO, etc.). Oversee calibration, qualification, and maintenance of instruments (HPLC, GC, FTIR, UV, KF, etc.). Review and update SOPs, STPs, GTPs, ...

Key Responsibilities: Perform in-process checks during manufacturing and packaging (weight variation, hardness, friability, disintegration, pH, viscosity, leak test, etc.). Ensure batch manufacturing records (BMR/BPR) are correctly filled and compliant. Monitor line clearance, environmental conditions, and GMP practices on shop floor. Review and verify critical process parameters (CPP) and ensure adherence to SOPs. Check and approve ...

Key Responsibilities: Handle QMS activities including CAPA, Change Control, Deviation, and OOS/OOT. Prepare, review, and maintain QMS documentation as per cGMP and regulatory guidelines. Support internal audits, external audits, and regulatory inspections. Ensure timely closure of quality incidents and continuous improvement initiatives. Coordinate with cross-functional teams for compliance and quality culture. Requirements: B.Pharm / M.Sc (Chemistry) with ...

 Key Responsibilities: Perform analysis and testing of Raw Materials (RM), Packaging Materials (PM), in-process samples, finished products, and stability samples as per pharmacopoeia standards. Operate, calibrate, and maintain analytical instruments such as HPLC, GC, UV, IR, Dissolution Apparatus, etc. Ensure timely release of materials/products with accurate and complete documentation. Maintain records, calibration logs, data ...

Key Responsibilities: Conduct routine microbiological testing (water, environment, raw materials, in-process & finished products). Perform environmental monitoring of cleanrooms, utilities, and aseptic areas. Support media fill, sterility testing, endotoxin testing, and microbial limits testing. Ensure compliance with cGMP, SOPs, and regulatory guidelines (USFDA, EU, WHO, etc.). Review and document microbiological data, deviations, and OOS/OOT investigations. Participate ...

Position:          Executive/Asst. Manager - QA Location:         Silvassa Experience:      2 - 10 Years Industries:       Pharma Responsibilities:       Ensure compliance with GMP, regulatory guidelines, and quality standards in pharmaceutical formulation manufacturing. Manage quality systems, audits, documentation, validations, and batch release while leading the QA team. Implement and maintain Quality Management ...

Job Description: We are seeking a skilled and experienced microbiology professional to lead microbial testing and environmental monitoring activities in an API manufacturing setup. The Assistant Manager will ensure compliance with regulatory standards, supervise microbiological operations, and support quality systems in the microbiology lab. Key Responsibilities: Oversee routine microbiological testing of raw materials, ...

Job Description: We are hiring an experienced QC professional to lead and manage quality control operations in our API manufacturing unit. The Assistant Manager will be responsible for supervising analytical activities, ensuring regulatory compliance, handling audits, and supporting continuous improvement initiatives. Key Responsibilities: Supervise routine analysis of raw materials, intermediates, and finished APIs Review ...