We are looking for young and dynamic personnel from Pharma background with proven track records, who have exposure to advance / regulated market operations (USFDA) for OSD, Sterile Injectable & Ophthalmic Products formulation USFDA Approved Unit at Paonta Sahib Location in
Designation: Senior Executive / AM – Technology Transfer
- Experience: 8 – 12 years
- Education: B.Pharm / M.Pharm
- Location: Paonta Sahib
- Audit Exposure: USFDA(Mandatory)
- Handling of sterile formulations for regulatory markets like Oncology injections, lyophilized Injection, eye drops, emulsion, suspension, complex injectable, sterile API manufacturing etc.
- Execution of trial, scale up, exhibit, process validation batch at respective manufacturing site
- Evaluation of tech packs information on tech transfer and site transfer projects.
- Knowledge on process validation / submission and automated equipment’s at each step of manufacturing.
- Performing Gap analysis / process comparison / Technical risk assessment.
- Handling of Incident report, Deviation and Change control as per requirements. Perform Gap analysis / process comparison / Technical risk assessment.
- Literature review of NDDS project and execute pilot scale batches in Technology Development Laboratory.
- Evaluate new products on basic of Quality by design approach, containment approach and check feasibility on existing manufacturing set up or additional control.
- Products gap assessment, risk assessment between R&D to Plant.
- Commissioning of new manufacturing equipment monitoring and alarm systems, or execution of validation protocols in the cleanrooms as requested.
Share updated profiles at firstname.lastname@example.org. Kindly mentioned your Current CTC, Expected CTC, Current Designation & Expected Designation in mail while sending resume.
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