55 Job openings found

Key Responsibilities: Manage and oversee all Quality Control activities for formulation products. Ensure compliance with cGMP, GLP, and regulatory guidelines. Review and approve analytical reports, COA, STP, and specifications. Handle instrument operations like HPLC, GC, UV, Dissolution apparatus, etc. Ensure calibration, validation, and maintenance of QC instruments. Coordinate with QA, Production, and R&D for smooth operations. Handle ...

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 ...

Designation: Training Manager Education: Pharmacy/M. Pharmacy Experience: Minimum 12-15 years of experience in production, training and development role in the pharmaceutical industry. Technical Knowledge: In-depth knowledge of Manufacturing and Packaging process. In-depth knowledge of QMS, Batch record, Risk assessment, Qualification and cleaning validation. In-depth knowledge of Operation & Cleaning of pharmaceutical equipment’s and SCADA system. In-depth knowledge of data ...

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: 1. Quality System Management Implement and maintain the Quality Management System (QMS) in compliance with ISO 17025 / GLP / GMP / NABL standards. Prepare, review, and control QA-related documents such as SOPs, policies, forms, and records. Ensure timely calibration, maintenance, and validation of laboratory instruments. Conduct internal audits and coordinate external audits ...

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 ...