Biophore India Pharmaceuticals – Walk-In Interviews for DQA / QA / Analytical Development on 24th Dec’ 2022

Founded in 2007, Biophore has established itself as a trusted partner for niche and complex products. With 4 US FDA and EU approved API manufacturing facilities, one dedicated intermediate facility and a world class  R&D lab housing 400 scientists with varied expertise, Biophore has emerged as one of the leading API companies globally. We have consistently been in the Top 10 US DMF filers with the US FDA over the past 5 years and with most of our APIs, we are one of the fastest companies to bring them to the market enabling wider access for patients worldwide

Walk-In Interview for Formulations DQA / QA – R&D Exp @Pashamylaram

• Experience: 1-4 yrs
• Qualification: M.Sc / M.Pharm
• Job Location: Hyderabad

Development Quality Assurance / Formulation Quality Assurance R&D:

• Product development with QbD approach
• Literature Search and Technical Patent Review
• Pre-Formulation Development
• Drug-Excipient Compatibility Studies
• Formulation Development and Optimization
• Process Development and Optimization
• Scale-Up and Technology Transfer
• Process Validation Studies
• Packaging Development Studies

Analytical Development

• Analytical method development for drug product
• Analytical method validation for drug product
• Stability studies to support regulatory fillings
• Cleaning methods for drug products
• Analytical Method transfers of drug product

Related Jobs: NATCO PHARMA LIMITED – Walk-In Interview for Chemical R&D / API R&D / Synthesis R&D on 24th Dec’ 2022

 

Others :

• Responsible for implementation and Compliance of Quality Management System in Formulation R&D Division.
• Qualification of External Sites (CROs, CMO’s and contract testing labs).
• Internal Audits and procedures.
• Review of QMS documents Change Controls, Incidents, Laboratory Event Investigations, Data Correction Control, Ratification ,Errata ,Internal Audit Reports, Qualification reports, Calibration schedules, etc.
• Review of Formulation development documents and Technology Transfer documents.
• Review of Analytical Validation and Analytical tech Transfer documents.
• New SOP implementation and Harmonization of procedures and practices for all the departments.
• Conduct intra/inter departmental training workshops as per the requirement