Quality Assurance - R & D
- NMS Consultant
- 4 to 8 Yrs
- Mumbai
- 5 years ago
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Job Description
- Review of Master Manufacturing Formula for New and revision.
- Review Formulation Development Report (FDR).
- Review development report for Injectable products (Sterile solutions, Lyophilized powder,
- Suspension and emulsion etc.)
- Review in-house studies protocol (i.e. Reconstitution/ dilution study) and reports of R&D trial batches.
- Review R&D batches stability data.
- Review elemental impurities assessment/reports as per ICH Q3D for Injectable products.
- New change control initiation and review and provide impact assessment for implementation of change control and verify the implementation of approved changes.
- Review of deviation and conduct investigations to identify the root cause and propose CAPA as Excrequired.
- Ensure the implementation of all CAPA.
- Preparation of master formats, issuance as per relevant SOP's.
- Review of scale-up protocol and report.
- Review of Qualification activity for newly installed equipment's and instruments at R&D
- Perform sampling of Finished Products, Active Raw material and excipients used in
- manufacturing of pilot bio batches.
- Preparation of Design trials for process and formulation in Design Expert Software and
- preparation of stability data regression in Minitab software.
- Having experience of development in dosage forms like Complex Injectable, Parenteral, Solid
- Oral, Liquid, Semisolid, Suspension, Capsules, Ointment, Gel etc. and handled DQA requirement and internal audit for these areas of labs for compliance.
- Study, Material Contact Study, Hold Time Study, Excipient Compatibility Study, Extractable
- Leachable Study and Glass Delamination study) of Complex Injectable & Parenteral Products and implementation of DQA policies and SOPs in these areas as per requirement.
Employement Category:
Employement Type: Full timeIndustry: Pharma / BiotechRole Category: Quality (QA-QC)Functional Area: Not ApplicableRole/Responsibilies: Quality Assurance - R & DContact Details:
Company: NMS Consultant HiringLocation(s): Mumbai+ View Contact
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