Work as Regulatory Affairs Manager in Synapse Labs
Post: Regulatory Affairs Manager
Job Description:
• 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.
• HPLC
• UV-VIS spectrometer
• FT-IR Spectrometer
• Dissolution Apparatus
• Autotitrator
• 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.
Additional Information:
Experience:1-3 years
Location: Pune
Education: M.Pharm, B.Pharm
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: DRA
Email your resume, careers@synapselabs.com
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