Work as Regulatory Affairs Manager in Synapse Labs
Synapse Labs is a Contract Research Organization (CRO) which offers a range of services to the Pharmaceutical and Biotechnology industry. We are dedicated to quality service, with focus on reducing time and cost, We are achieving this by understanding client requirement and working close with them to match their timeline.
Post: Regulatory Affairs Manager
• Preparation of Master Formula Records based on the tentative proposed manufacturing guide.
• Preparation of Batch Manufacturing records with batch packing details as per Standard MFR.
• Preparation of Product Master Data for various products for export.
• Preparation of specification for packing material & finished product.
• Preparation of Annual product review.
• Documents distribution & Documents control.
• Correspondence with the loan licensees concern with QA and QC activities
• Process Validation Protocol.
• UV-VIS spectrometer
• FT-IR Spectrometer
• Dissolution Apparatus
• Hardness tester
• Friability tester
• Analysis of finish product creams, tablets and packing material.
• Calibration of Instruments.
• In process quality Control and Quality checks for various dosage forms.
Education: M.Pharm, B.Pharm
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: DRA
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