22 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 ...

Position:         Asst. Manager/ Manager - ADL Location:         Vapi Experience:      8 - 10 Years Industries:       Pharma - API  Responsibilities: Analytical Development & Validation   Lead development, optimization, and validation of analytical methods for APIs, intermediates, and finished dosage forms. Perform method validation as per ICH, USP, EP, and IP ...

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 ...

Job Title: R&D Executive – Dossier / Regulatory Affairs No. of Positions: 3Company: Concept PharmaLocation: AurangabadCTC: ₹NegotiableExperience:  1–2 YearsQualification: B.Pharm / M.Pharm Job Summary Concept Pharma is seeking R&D Executives (Dossier / Regulatory Affairs) to support preparation, compilation, and submission of regulatory dossiers for pharmaceutical products. The role is suitable for freshers as well as candidates with up to 1–2 years ...

Key Responsibilities: 1. Method Development & Validation Develop analytical methods for assay, dissolution, related substances, and stability testing. Conduct method validation as per ICH guidelines (accuracy, precision, specificity, linearity, robustness). Optimize and troubleshoot existing analytical methods. 2. Instrument Handling Operate analytical instruments such as HPLC, GC, UV, FTIR, KF, Dissolution Apparatus, etc. Perform daily calibration and ensure ...

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 ...

Job Summary: We are seeking an experienced and dynamic R&D Sr. Manager / Manager to lead API process development and optimization projects. The role involves overseeing laboratory research, scale-up, and tech transfer of API processes, ensuring timely delivery, compliance with regulatory standards, and alignment with business goals. Key Responsibilities: Lead end-to-end API development ...