Exemed Pharmaceuticals – Job Openings for ADL / Production / International Regulatory Affairs – Apply Now

Exemed Pharmaceuticals – Job Openings for ADL / Production / International Regulatory Affairs – Apply Now

Exemed Pharmaceuticals – is a leading Manufacturer, Supplier of Bulk Drugs Powder , Bulk Drugs Intermediates, Sodium Formate Powder from Vapi, Gujarat. Exemed is a venture being initiated by a business group involved in manufacturing of Drug-intermediates & speciality chemicals, for more than three decades, having a reputation for high quality & reliability. Exemed offers end to end solutions starting from Intermediates, APIs to Finished formulations with a strong R&D team and world class manufacturing infrastructure.

Required ADL – Officer / Sr. Officer / Executive

Job description (JD):

Qualification: Masters (Chemistry

Candidate should have following criteria:

1] Experience of 1-6years in ADL / QC.

2] Handling instruments like HPLC and GC-Headspace.

3] Handling other analytical instruments like KF-Titrator, Auto-Titrator, pH-meter, Polarimeter, UV Spectrophotometer, Balance etc.

4] Analysis of In-process monitoring, Raw material, Intermediates, Stability studies and Drug substances (API).

5] Analytical method development and analytical method validation exposure.

6] Calibration of analytical instruments

7] Should follow GLP practices, Document preparation for Specifications, SOPs, Certificate of analysis and technical reports.

Email : [email protected]

DEPARTMENT: Production

  • Minimum education qualification of B.Sc./ M.Sc. Chemistry
  • Experience in API manufacturing 1 to 5 years, Salary: 2 Lacs to 3.5 Lacs.

Roles & Responsibilities:

  • Accountable for entire shift activity for the respected area related to manufacturing plants (Chemical Area, Purification Area and Powder Processing Area) & solvent recovery plant.
  • Accountable for providing material transferring note to warehouse of finished API as per production.
  • Responsible for powder processing area activity.
  • To ensure the availability of raw material as per BMR/BPR with approved status.
  • Responsible for issuance of raw material and packaging material.
  • To operate and monitor the running batches as per BMR and written instructions.
  • To plan the batch charging as per production planning.
  • To perform other activity with respect to Approved SOPs.
  • Communicate to section In charge/Executive for Deviations, Process delay, Break down, and any failure regarding safety and GMP.
  • To distribute and to instruct for the work to sub-ordinates.
  • To fill on line documents like BMR, ECR, Log book and area related documents.
  • Accountable for housekeeping of area and cleanness of equipments, pipe lines, tanks and other manufacturing items as per SOP.
  • To co-ordinate for sending request to other departments during shift.
  • To follow safety and GMP norms.
  • Responsible for preparation of plant related documents.
    • Updating of status boards and labeling during shift for equipment and Materials.

    If interested, please share updates resume mentioning current & expected CTC on [email protected]

    Required Officer/Sr Officer- International Regulatory Affairs

    • Company Name : Exemed Pharmaceuticals (Formulation Division)
    • Designation: Officer/Sr Officer- International Regulatory Affairs
    • Location: Vadodara -Corporate Office
    • Experience– 3 to 5 Years (IRA-Formulation)
    • Qualification req.: Master of Pharmacy (Pharmaceutics)

    Countries Handled – ROW

    • ASEAN-Thailand, Philippines, Malaysia, Myanmar, Vietnam, Cambodia,
    • EAST ASIA-China (Hong Kong), Mongolia,
    • CIS-Georgia, Uzbekistan, Ukraine, Tajikistan,
    • SOUTH ASIA-Bhutan,
    • CENTRAL AMERICA-Costa rica, Dominican republic, Mexico,
    • SOUTH AMERICA-Bolivia, Chile, Colombia, Ecuador, Paraguay, Peru,
    • AFRICA-Kenya, Namibia, Uganda Zambia, Zimbabwe, Ivory coast,
    • GCC-Algeria, Iraq, Yemen
    • Job profile:

      1. To prepare, review and submit dossiers in ROW market as per CTD, ACTD and country specific format.

      2. Should have knowledge about various guidelines i.e., ICH guideline, WHO guideline, CTD guideline, Country specific guideline and requirements.

      3. To communicate with various departments i.e., Production, Quality assurance, Quality control, Artwork, Purchase, Clinical for dossier documents.

      4. To review and finalize various plant documents for dossier preparation. i.e., API spect, MOA, COA, Product development report, BMR, Multimedia dissolution profile, Process validation protocol and report, finished product Spect, MOA, COA, Analytical method validation/Verification, Reference std. Working standard, Packing material Spect, MOA, Stability data, Stability protocol, Raw data.

      5. To review Drug master file and various accreditations received form approved Vendors and share queries if arises for submission.

      6. Be responsible handling queries raised by regulatory bodies for product registration process independently.

      7. To communicate with various Customers for Dossier and query response submission.

      8. Be responsible for sample submission, working standard submission, COA submission to various markets for Product registration.

    • To prepare text matter for Pack Insert, Carton & Foil as per different MoH requirement.

      10. To apply Product permission, CoPP and FSC application in FDA portal.

      11. To prepare PSUR, Clinical and Non clinical documents by literature references.

      If interested, please share updated resume on [email protected] with current & expected CTC.

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