Impel Talent is building a Drug Product MSAT team of key pharmaceutical experts for a state-of-the-art facility. Part of that team is a Lead Validation Expert to oversea and own the Transport Validation area for Drug Substance and Drug Product.
You will create written procedures to support a wide portfolio of products entering global markets as a the transport validation SME.
Key responsibilities and minimum requirements according to job level:
- Responsible for leading the Transport validation activities for the Drug Substance, Drug product and Finished product presentations.
- Be an SME author/reviewer and/or approver for written procedures, SOPs, protocols, sample plan and reports etc. related to Transport Validation.
- Responsible for performing process risk assessments. Be an SME author for performing risk assessments relating to transport validation processes.
- To be a key team member contributing to successful commercial Pre-Approval Inspections (PAIs), regular Audits and any other interaction with regulatory agencies as required.
- Responsible for addressing the regulatory queries and dossier review for transport validation sections.
- Be a single point of contact (SPC) for Transport validation responsibilities.
- Be an SME author of Deviations, CAPAs and change controls.
Minimum education and experience required for the role:
- Education: Education: Master’s in pharmacy in Pharmaceutical Biotechnology.
- Experience: 10- 15 Years in the field of Biopharmaceutical Industry.
If you are interested, please apply immediately as interviews begin this week.
