Ph.D. or M.Sc./M. Pharm in Chemistry, Pharmaceutical Science, Analytical Science, or other relevant field; Provides leadership to scientists working in monograph and standards development and revision by established SOPs, business practices, and procedures.
Review of technology transfer documents and initiate the validation accordingly in plant scale by coordinating with CFT. Review of Master Batch Manufacturing records executed Batch manufacturing records.
For over 75 years, Bioplus has served the pharmaceutical industry with high quality products, service, and technology. While continuing to build our global partnerships in Contract Manufacturing and EU / ANZ pharma generic pharmaceuticals, we are increasingly focused on utilizing our advanced skill set in Biotechnology. Today we are a late-stage clinical phase company with 2 programs for large global unmet needs both of which are Clinical phase 3 ready.
Pharmacy or Biological Science Graduate, Post graduate. 10 to 15 years of field work experience in pharma Industry Preferably 1 year as a training manager in field or in corporate
To manage multiple site Regulatory with multiple dosage forms. To Develop strategies and ensure to comply with Regulatory Bodies. Filing strategy documents for emerging markets and active Involvement in tender Business.
Subject Matter Expert for Drug-Device Combination Products will serve as a key resource within the organization for technical expertise and regulatory guidance related to the development, manufacturing, and commercialization of drug-device combination products.
Responsible for analytical method development, analytical method validation, stability study, method transfer and other end to end projects analytical activities. Responsible for assigned lab compliance activities.
Analytical Method Development of various pharmaceutical dosage forms like oral solid, oral liquid, Injectables, Nasal Spray. Analytical Method Validation of various pharmaceutical dosage forms like oral solid, oral liquid, Injectables, Nasal Spray.