Opening For Technology Transfer
- Pharmaceutical
- 3 - 6 years
- Ahmedabad
- 3 years ago
- Email to a friend
- Report this job
Job Description
Opening For Technology Transfer (Domestic/Emerging Market)
Key Accountabilities/ Responsibilities
1. Process evaluation trials with F&D Scientists
- Perform process feasibility check.
- Perform process optimization trials with F&D scientist.
- Planning of scale-up batches with F&D scientist.
- Review of documents like; MFC, FPS (Finished Products Specifications), scale-up batches report.
2. Alternate Vendor Development
- Perform trials on API and excipients for alternate vendor development.
- Generate stability data for AV.
- Documentation compilation.
3. Reformulations
- Perform feasibility trials with new strategy for commercial issues or cost reduction.
- Perform process optimization trials.
- Prepare documents like; MFC, FPS, FRM.
- Transfer of product to production for validation batches.
4. CMO Batches
- Tech pack review and data compilation for feasibility check.
- Perform feasibility trials and process optimization trials.
- Documentation preparation for MFC and put request for FPS (Finished Products Specifications) with ADL team.
5. Batch transfer
- Feasibility check for machines and batch size proposals.
- Review of plant documents like BMR and validation reports.
- Execution of exhibit batches.
- Process monitoring at each stages from dispensing, granulation, compression / capsule filling, coating and packing.
- Data compilation for exhibit batches.
- Online trouble shooting.
6. Commercial batches validation
- Execution of commercial batches.
- Process monitoring at each stages from dispensing, granulation, compression / capsule filling, coating and packing.
- Data compilation for commercial batches.
- Online trouble shooting.
7. Documents preparation
- MFC (for CMO / Reformulation), FPS, FRM (Raw Material specification).
Candidates should also have sound knowledge cGMP documentation and must be familiar with cGMP requirements.
Interested candidates may also email their resume to ca***r@un******************s.com
Job Classification
Industry: Pharma, Biotech, Clinical ResearchFunctional Area: Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology,
Role Category: R&D
Role: R&D
Employement Type: Full time
Education
Under Graduation: B.Pharma in Any SpecializationPost Graduation: M.Pharma in Any Specialization, MS/M.Sc(Science) in Any Specialization
Doctorate: Any Doctorate in Any Specialization
Contact Details:
Company: Unison Pharmaceuticals Pvt LtdAddress: C / 7,8,9, STEEL TOWN,OPP. NOVA PETRO, VILL MORAIYA,,T, AL - SANAD, , AHMEDABAD, Gujarat, India
Location(s): Ahmedabad
Keyskills: TT Process Development Technology Transfer
Pharmaceutical
Unison Pharmaceuticals Private Limited (Formerly known as Unison Pharmaceuticals) was established in 1981 with a vision of providing quality and most affordable medicines across the nation. With more than 4 decades of medical service to the society, Unison is today one of the fastest growing com...
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