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:       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, ...

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 ...

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 ...