Biocon is a research-driven, global healthcare company with a strong matrix of capabilities along the biopharmaceutical value chain. Focusing on unmet medical needs in cancer, diabetes and inflammatory diseases, it offers novel therapies on a platform of affordable innovation.
Biocon together with group companies employs more than 2500 employees with approxmimately Rs 1,000 crore turnover and is expected to grow further during the current financial year.
Post: Deputy Manager- HC/JC/2306/12
Job Description
* Demonstrate familiarity with generic solid oral & parenteral formulation manufacturing process; especially at small scale manufacturing like R&D operations.
* DQ/IQ/OQ/PQ of various process equipments like RMG, Tablet Press / compression machine, Capsule filling machine, Fluid bed Processor, Dryer, Milling, Tablet coating m/c, Blister packing m/c, etc.
* Sphere head periodic calibration and scheduled maintenance of all equipment in R&D.
* Utilize knowledge, experience & strong conviction for best documentation practices as per cGMP / GLP requirements.
Must be aware of CAPA, OOS, OOT, Incidences, Investigations, etc.
* Experience of handling SOPs, Log books, Batch records, training records etc is must.
* Writing, reviewing & approval of SOPs for R&D processes, guidance’s, equipments etc.
* Implementation of QbD in R&D product development with help of technical teams.
* Designing training modules for new joiners’ & maintaining training logs for all employees.
* Review & approval of formulation, process and analytical documents at pre-defined intervals (like pilot, scale-up, Exhibit batch execution & dossier submission).
* Conducting internal audits for formulation & analytical facilities to ensure compliance at all appropriate stages during development.
Skills:
Diploma / Certification in Pharmaceutical Quality / Six Sigma / cGMP preferred Prior experience in Quality assurance / Quality control of formulation products or in Quality assurance of R&D / Pilot plant. Earlier experience in production / formulation / analysis will be preferred
Additional Information:
Experience: 2-8 Years
Qualification: M.Pharm, M.Sc, M.Tech
Industry Type: Pharma/Biotech/Clinical Research
End Date: 7th Feb, 2013
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