38 Job openings found

Job Description: We are seeking a dedicated QMS professional to oversee and maintain the Quality Management System in compliance with cGMP and regulatory requirements. The role involves managing documentation, handling quality events, and supporting internal and external audits in an API manufacturing environment. Key Responsibilities: Implement and maintain QMS processes in line with ...

COA/ Certificate of Analysis MSDS Specifications/ TDS Method of Analysis Stability Data DMF/ Drug Master File Declarations Preparation of Vendor Questionnaire Customer response for technical queries Must have knowledge of Pharmacopoeias, ICH guidelines   COA/ Certificate of Analysis MSDS Specifications/ TDS Method of Analysis Stability Data DMF/ Drug Master File Declarations Preparation of Vendor Questionnaire Customer response for technical queries Must have knowledge of Pharmacopoeias, ICH guidelines,

Position:         RA Executive (Khopoli) Location:        Khopoli - Raigarh Experience:     5 - 6 Years Industries:      Pharma    Responsibilities: Dossier Preparation & Submission Prepare, compile, and review CTD / ACTD / eCTD dossiers for product registration in global markets. Coordinate for ANDA, DMF, CEP, COS, and other regulatory submissions for APIs and ...

Require engineer experience of break down & trouble shooting, routine repairs and maintenance activities of all Formulation equipment's. Required experience of vial & ampoule line equipment's of injectable facility, handling maintenance of machines like Vial washing, Vial Filling & sealing machine, Rotary washing, Filling & Sealing, Dry Powder Line, inspection & ...

Require engineer experience of break down & trouble shooting, routine repairs and maintenance activities of all Formulation equipment's. Required experience of vial & ampoule line equipment's of injectable facility, handling maintenance of machines like Vial washing, Vial Filling & sealing machine, Rotary washing, Filling & Sealing, Dry Powder Line, inspection & ...

JOB DESCRIPTION – SAS ProgrammerGraduate/Post-Graduate in Statistics/Mathematics/Computer Science/Life Sciences.A minimum of 6+ years of experience in Statistical programming and/or design and analysis of Phase I toPhase IV clinical trials in a Contract Research Organization or Pharmaceutical or Biotechnology company Thorough knowledge of the pharmaceutical industry including understanding of clinical drugdevelopment ...

1. Review overall QC documents.2. Prepare training modules as required and provide training to QC staff.3. Initiate and approve analyst qualifications as needed.4. Approve COAs for water analysis from the microbiology department.5. Review microbiological analytical reports, raw data sheets, and inward registers for finishedproducts.6. Prepare and validate Excel sheet calculations.7. ...

Position:         Trainee - Production/Quality Location:        Dabhel - Daman Experience:     0 - 1 Years Industries:      Pharma    Responsibilities: Production (Manufacturing) Support: Assist in batch manufacturing processes such as granulation, compression, coating, filling, and packing under supervision. Follow Standard Operating Procedures (SOPs) and Batch Manufacturing Records (BMRs). Ensure cleanroom hygiene, gowning practices, and compliance ...

Position:         RA Trainee(Khopoli) Location:        Khopoli - Raigarh Experience:     0 - 1 Years Industries:      Pharma    Responsibilities: Assist in the preparation and compilation of regulatory dossiers (CTD / ACTD / eCTD) for product registration in various markets. Support the collection and review of technical documents from R&D, QA, QC, and Production ...

Position:        QA Officer Location:        Vapi Experience:    2 - 5 Years Industries:     Pharma   Responsibilities:         Documentation & Record Review: Review specifications, sampling instructions, test methods, and analytical reports. Review and approval of Batch Manufacturing Record (BMR), Batch Packing Record (BPR), Master Formula Record (MFR), and Equipment Qualification Records. Review completed Batch ...