14 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:        RA Officer Location:       Daman Experience:    0- 3 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 pharmacopoeia, ...

Essential Duties and Responsibilities:We are seeking a dynamic technical documentation Executive with a minimum of 1 years of experiencein the Chemicals & Pharmaceuticals industries. The ideal candidate will be responsible for thepreparation and processing Key responsibilities include. A. Preparation of Technical documents like below:1. COA/ Certificate of Analysis2. MSDS3. Specifications/ TDS4. ...

  Job Description -    20.12.24   HPS/2024/802 Inward (Q.A) Male 1 2 to 3 DME / B.E (Mech)   An inward quality assurance (QA) inspector, or quality inspector, is responsible for ensuring that products and materials meet company requirements. Their duties include:    Inspecting: Reviewing incoming materials and products to confirm specifications, and conducting visual and measurement tests    Approving: Approving finished products, and releasing product processes    Identifying defects: Identifying defects ...

  Role & responsibilities   Design, finalize and propose specification of KSM, Intermediates and finish API as per developed control strategy. Prepare the documents for Process development report and technology transfer. Develop cost effective, high quality and minimum environmental hazardous process considering ICH guideline. Finalize the route of synthesis after doing feasibility study of ROS to ...

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 & ...

2-5 years of working experience on Dynamics 365 F&O and Dynamics AX Knowledge of Coding in X++, MorphX, SSRS Report development, .net mandatory Knowledge of working on previous versions of AX (2009,2012,2012 R2/R3) Knowledge of building SQL queries for analytical requirement of Dynamics database Familiarity with DevOps, TFS, LCS Knowledge/experience of various integration methods like ...