Rubicon Research is a product development company based in Nahur,Mumbai, India and is recognized as a world class outsourcing partner in pharmaceutical industry, serving Fortune 500 companies worldwide. We are a fast growing, young organization of 250 employees with significant experience in the field of formulation development and providing a full spectrum of development services from preformulation to registration. We also have our GMP manufacturing plant from where we provide commercial supply chain.
Post: Corporate Quality Assurance- 3 Nos.
* Review , check for approval of Raw data (LNBs), technical documents (MFC, BMR, AMDR, PDR) & DATA AS PER Regulatory requirements
* Applications for import licenses, local FDA licenses, NOC for export and other regulatory license applications. Follow ups for receipt of licenses etc
* Prepare , Review , Check Quality system Documents (SMF, VMP), SOPs, CAPA, change control, deviations, OOS investigations and release of pilot scale batches for clinical studies
* Conduct Internal audits. Manage client audits at R&D Plan, follow up , ensure compliance of facility, utility, calibration, preventive maintenance and operational monitoring (log books) and qualification systems at R&D
* Managing the QA team and training them on all quality systems.
Department: Corporate QA
Job Location: Nahur-Mumbai
# Background : Should have exposure to regulated markets (US/UK/Europe) in the last couple of years. QA experience in Oral Solid Dosage formulation.
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"Industry Type: Pharmaceutical(Formulation)
End Date: 15th March, 2015
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Rubicon Research Pvt.Ltd.
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