35 Job openings found

Job Description:  Experience in handling regulatory affairs for ROW market mainly Central and Latin American, African & Asian countries for Pharma Formulations. ? Preparation, Compilation & Review of Registration documents that include Administrative & Technical. ? Reviewing the technical documents provided by QA, QC, Production providing them the report of shortcomings & ...

ompile, author, and maintain Type III Drug Master Files (DMF) for the US FDA, Health Canada, and equivalentregulatory submission dossiers for European (EDQM) and Asian regulated agencies.Coordinate the preparation of comprehensive technical dossiers covering raw materials, master-batchcompounding matrices (Halobutyl polymers), formulation ingredients, and vulcanization traits.Manage the swift completion of annual ...

The Junior Manager/Assistant Manager - Quality will lead the Quality Control (QC) and Quality Assurance (QA) team, ensuring all heavy fabrication activities (welding, fit-up, assembly) meet ISO 9001, AWS, ASME, or IBR standards. The role focuses on reducing rejections, managing third-party inspections (TPIA), and maintaining compliance for large-scale structural projects.    Key ...

  Key Responsibilities: Prepare, compile, and submit CTD/eCTD dossiers for EMA and DGMED (France) including new registrations, renewals, and variations. Coordinate with internal teams (QA, QC, R&D, Supply Chain) for document collection and compliance. Liaise with regulatory agencies and local representatives in the EU and France for query resolution and approvals. Ensure dossiers and product ...

Job profile. 1.      Dossier preparation and filling for product registration in International Regulatory bodies. 2.      Query replies to International regulatory authority for the dossier for product registration. 3.      Documents follow up with Production,QA and QC dept required for Dossier preparation. 4.      Regulatory Samples follow up for the product registration along with dossiers filling. 5.      Product finalization with clients as per ...

    Regulatory Affairs Officer (RA) Qualification: B.Pharm/ M.Pharm Experience: Minimum 3 years in regulatory affairs for the ROW (Rest of the World) market, with a total of 3 to 5 years of experience. Job Description: Preparing dossiers as per country-specific guidelines. Compiling and reviewing documents. Coordinating with QA for documentation. Addressing queries raised by respective countries' FDA. Bond: 18-month ...

Job Location : Mahape, Nearest Station Ghansoli (Navi Mumbai)   Look for people from Navi Mumbai or Mumbai Only   Only Female Candidates required   Qualification : B.Pharm / M.pharm   Experience : 1yr – 3yr   Salary : 1.42lpa – 2 .80lpa     Profile : Experience in preparing Dossiers in CTD, ACTD, Country Specific Dossiers.   Countries : ROW and Latum   Job Description: Dossier Preparation along ...

1. GMP Compliance: Implement Good Manufacturing Practices (GMP) to ensure productsafety and quality throughout the lifecycle.2. Documentation & SOPs: Develop, review, and maintain Standard OperatingProcedures (SOPs), batch records, and, in some cases, documentation for approvals orexports.3. Auditing: Conduct internal and external audits of manufacturing facilities.4. CAPA & Deviations: Manage deviations, ...

We are seeking an experienced and detail-oriented Senior QC Engineer to oversee and ensure product quality across all stages of manufacturing operations. The candidate will be responsible for implementing quality standards, conducting inspections, ensuring compliance with customer specifications, and coordinating with production teams to maintain high-quality output. Key Responsibilities: Quality Inspection ...

Lead and supervise all field instrumentation activities during construction, pre-commissioning, and commissioning phases. Ensure installation of field instruments, analyzers, control valves, junction boxes, impulse tubing, hook-ups, and instrument air systems as per AFC drawings. Verify installation compliance with P&IDs, instrument layouts, hook-up drawings, cable schedules, and specifications. Coordinate loop checking, functional testing, calibration, ...