24 Job openings found

DMF API Submission experience is must Preparation of New Drug Master Files as well as DMF amendments for Brazil, US, and ROW market according to respective agencies requirements. Preparation of Applicant part of DMF for Brazil, US, and ROW market. Preparation of all administrative statements for respective authority requirements. Drafting of regulatory response for ...

Job description for API Regulatory: Preparation, review and submission of Drug Master Files/CEP in eCTD format for the regions US, EU through ESG and CESP. Life cycle management of the Drug Master Files (Amendments, Annual Reports, CEP updates). Preparation, review and submission of Applicant's Part DMF (Open Part DMF) and Technical data ...

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,

  Job Description -    20.12.24   HPS/2024/799 Maintainence Manager. Male 1 4 DMF / B.E (Mech)   Name of position: - Maintenance Manager Experience required - 4 years Qualifications required: - DMF / B.E (Mech) Age range: - Any CTC: 4.00 – 4.50 LPA Shift Timing: - General (9 am – 7 pm)    Skills required: - 1. Supporting and leading all Maintenance process & operations 2. Tracking ...

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 ...

Position:      QA/QC Specialist Location:      Umbergaon Experience:  6 - 7 Years Industries:  Medical Devices  Responsibilities: Quality Management System (QMS) Implement, maintain, and continuously improve the Quality Management System in accordance with CE, ISO 13485, ISO 9001, ISO 14001, ISO 45001, ISO/IEC 17025, and Indian MDR 2017 requirements. Ensure effective document control, change management, and ...

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, ...

Position:       Sr. Executive/Asst. Manager - RA Location:       Daman Experience:   5 - 8 Years Industries:     Pharma Responsibilities: Preparation of the dossier as per the current prescribed guidelines of the respective regulatory authorities Coordinate with various departments to collect the complete set of documents. Review of the quality and analytical data as per the ...

Roles & Responsibilities(API & Pharmaceutical Intermediates Manufacturing Company)1. Sales Planning, Target Setting & Market Development• Prepare monthly, quarterly, and annual sales targets based on production capacity,market demand, and business goals.• Develop strategic sales plans for APIs and pharmaceutical intermediates in domesticand export markets.• Identify new business opportunities in pharma companies, ...

To review and implement a Quality Management System for cGMP compliance at the Production (Injectable) plant. To prepare, Review and Approve BMR, BPR and related documents. Handling of Caliber QAMS, DMS, Nichelon 5 CMS, Dynamic, Schedule and Track and trace Serialization & aggregation. Giving the required training also Responsible for Media fill and ...