14 Job openings found

Job title : Supervisor - GMP DocumentationDesired Qualifications : BSc./MSc./Diploma (Chemical)Experience Required : 1.0 Years+Industry : Pharmaceutical/ Fine/Speciality ChemicalsJob Function Dept- : Production (GMP)Location : DahejTechnical:? Having Batch processing experience on shop floor and familiar with equipment like reactor,centrifuge, dryer etc.? Having basic awareness about unit operation and unit process.? ...

Position:        Maintenance Engineer Location:       Vapi Experience:    2 - 5 Years Industries:     Pharma - API Responsibilities: Core Documentation Responsibilities Equipment & Facility Documentation Maintain and control engineering drawings, P&IDs (Piping & Instrumentation Diagrams), equipment manuals, and spare parts lists Manage equipment qualification documents (IQ, OQ, PQ) and requalification schedules Create and update equipment files, ...

Position:      Sr. Executive/Asst. Manager - QMS Location:       Ahmedabad Experience:    5 - 12 Years Industries:     Pharma   Responsibilities Ensure effective implementation of QMS requirements within the Production department. Prepare, Review, initiate, investigate, and monitor deviations, incidents, OOS/OOT, change controls, CAPA, and risk assessments related to Production. Coordinate with QA, QC, Engineering, Warehouse, and ...

Key Responsibilities Knowledge of GDP & GMP documentation and compliance. Preparation and handling of Investigation Reports, Complaint Reports, and related documentation. Preparation of SOPs, BPRs, ECRs, Qualification Protocols, and Reports. Sound knowledge of SAP and DMS systems. Proficient in MS Word, Excel, and PowerPoint with good typing speed. Handling of Deviation, Change Control, Complaints, Risk Assessment, ...

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 ...

Key Responsibilities: Ensure compliance with cGMP, GLP, FDA and regulatory requirements. Lead QC team operations, daily task allocation and technical troubleshooting. Review analytical raw data, HPLC/GC audit trails, SOPs and batch release documents. Lead investigations related to OOS, OOT, deviations and incidents, including RCA and CAPA. Manage stability studies, instrument calibration, analytical method validation/transfer and ...

Key Responsibilities Perform analysis of raw materials, in-process samples, finished products, and stability samples. Operate and maintain laboratory instruments such as HPLC, GC, UV, FTIR, and other analytical equipment. Prepare, review, and maintain QC documentation, test reports, and laboratory records. Follow Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), and data integrity requirements. Ensure compliance ...

Position:        Production Chemist/Officer/Executive Location:       Vapi Experience:    0 - 3 Years Industries:     Pharma API  Responsibilities: Handling API production activities as per BMR/BPR Monitoring process parameters and maintaining batch records Ensuring compliance with GMP and safety norms Coordination with QA/QC and Engineering departments Maintaining proper documentation as per regulatory requirements Requirements :  Logical thinking. Organizing. Good in communication. Basic ...

Oversee day-to-day production activities for formulation batches as per approved BMR/BPR. Ensure compliance with cGMP, GDP, and regulatory guidelines (WHO, EU, USFDA, MHRA as applicable). Monitor production planning, batch scheduling, material requirement, and manpower allocation. Coordinate with QA, QC, Warehouse, Engineering, and RA for smooth production operations. Review and ensure timely completion of batch ...

Responsibilities: QA Executive   To assign control number of Change control, Deviation, CAPA, OOS, OOT etc. To handle QMS related documents and its applicable Quality trends. To review investigation reports for deviation, OOS, OOT, OOE & Market Complaint. To coordinate for Internal Audit. To Issue and retrieve of Batch Production Record and Equipment Cleaning Record for ...