35 Job openings found

Key Responsibilities:•Handling of QMS tools like change control, CAPA, Deviation etc.•Handle QA efficiently and able to maintain documentation as per GMP.•Preparation and maintenance of training schedule and co-ordinate with working staff to establish Procedures, Standards and System.•Preparation of Raw Material and Finished Product specification in accordance with Regulatory Guideline.•Vendor Evaluation, ...

Job Description: Production Operator We are looking for skilled and reliable Production Operators with hands-on experience in API manufacturing. The ideal candidate will be responsible for executing day-to-day production activities, ensuring efficient batch processing, and maintaining GMP and safety standards. Key Responsibilities: Perform routine production operations such as batch charging, centrifugation, material handling, ...

Responsibilities Perform and supervise In-Process Quality Assurance (IPQA) OR QA checks during API manufacturing operations. Conduct on-line review of Batch Production Records (BPR) and ensure adherence to approved procedures. Ensure sampling, line clearance, and process compliance as per GMP/cGMP norms. Identify, record, and support resolution of deviations, non-conformances, and quality incidents during manufacturing. Support quality investigations and prepare required ...

 Project Leadership: Lead the overall project, including design, erection, commissioning, and providing engineering support during commercial production. Regulatory Compliance: Obtain necessary permits from local bodies (GIDC, GPCB) and ensure compliance during the project and commissioning phases. Project Planning: Develop detailed project plans and execute design standards in alignment with ...

    Accountable to manage safe working operation in warehouse, Ensure self and team members consistently follow all EHS rules and procedures. Ensure to monitor safe MHEs operation in warehouse Ensure to maintain GMP in warehouse and monitor and prevent pest activity in warehouse Maintain cleanliness and hygiene level and 5s of warehouse and monitor ...

Environment/Pathogen Monitoring Program, Sampling & Testing of Pkg. material, raw material, finished goods, EMP sample preparation and sterilization microbiological media, Tracking, Weekly Biological indicator test for Autoclave, growth promotion test Should be aware of ISO & USP guideline for Microbiology. Good knowledge of GMP practices Responsible for Decontamination of Bio-hazard waste generated from ...

Key Responsibilities Perform laboratory experiments related to API process development and optimization. Develop cost-effective, scalable, and robust synthetic routes for APIs and intermediates. Conduct literature and patent searches to support process development activities. Prepare experimental protocols, technical reports, and development documentation. Execute technology transfer activities from R&D to Pilot Plant and Production. Investigate process-related issues and ...

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 ...

•Responsible to collect the raw ingredients, EMP(Environmental monitoring program)sample, Packaging, in process samples and finished product samples as per sampling plan and conduct test as per AN methods for salmonella, Enterobacter sakazakii, Escherichia coli, Total bacterial count, Staphylococcus aureus, shigella, Listeria monocytogen, coliforms and various yeast & mold. •Responsible for analysis ...

🔹 Key Responsibilities: Execute day-to-day operations in aseptic and sterile manufacturing areas Monitor LVP production activities in compliance with SOPs, cGMP, and regulatory guidelines Operate and maintain critical equipment including autoclaves, filling machines, and sterilizers Ensure strict adherence to safety, quality, and environmental standards Prepare, review, and maintain batch production records and related documentation 🔹 Qualifications ...