Opportunity for M.Pharm, MSc as Assistant Manager at Aurigene

Aurigene is a clinical stage biotech company committed to bringing novel therapeutics for the treatment of cancer and inflammation. Based in Bangalore and Kuala Lumpur, Aurigene has fully integrated Drug Discovery & Development infrastructure from Hit Generation to Clinical Development.

Post : Assistant Manager

Department : Development Quality Assurance & CMC Regulatory Affairs (Quality management Systems, Analytical Quality Assurance (DS & DP), Validations, Technology Transfers & GMP Compliance.)

Qualification : M.Pharm / M.Sc. (Pharmaceutical Chemistry / Quality Assurance / Analytical Chemistry / Organic Chemistry) with 10-14 years’ experience.

Job Location : Bangalore

Brief Profile
• Review analytical documents from early stage development, technology transfers to pilot production across CMOs.
• Review and approves product specifications, PDRs, technology transfers, analytical method development & validations, technology transfers, technical reports, manufacturing and document compliance to ensure conformance with regulatory submissions for API and Formulations.
• Involved as a key person in driving change & deviation management, OOS, OOTs and follow-up with CFT members for effective implementation of CAPA, verification of quality system & procedure from risk to product quality & patient safety.
• Demonstrated capabilities in handling quality events through risk assessment & mitigation, compliance to ensure quality attributes.

• Design, implement, lead and approve Development Quality Guidelines, data integrity, GMP trainings and ensure training practices to be followed to meet current regulatory standards.
• Keeps abreast of new sciences in own area through literature review, absorb and adapt the procedures; provide training on data Integrity, GMP procedures and on QMS.