- Reference: 44062
- Job Type: Permanent
- Location: Dublin City Centre, Dublin North, Dublin South
- Category: Production
Essential Duties and Responsibilities include, but are not limited to, the following:
• Serves as the primary contact for DP contract manufacturing sites concerning day-to-day activities. Responsible for developing and maintaining these important business relationships.
• Liaison between Quality Control, Quality Assurance, Supply and Development Departments and contract manufacturers or business partners.
• Ensure the timely routing and review of all master manufacturing records, standard operations procedures (SOPs), tech transfer reports, validation master plans, and other documentation related to clinical and commercial drug product manufacturing at contractors and/or business partners.
• Coordinated all filling activities at contract and/or business partner manufacturing sites, including but not limited to: scheduling of all batches, supplying of requested materials, directing shipment of bulk and finished product at manufacturing sites.
• Travel to contract manufacturers or business partners, as required.
• Provide regulatory filing support (IND, BLA, MAA, etc…)
• Maintain required training status on specific work instructions and SOP’s.
• Lead sub-team(s) in new projects, continuous process improvements, system implementations and/or strategy development
• Write internal investigation or deviation reports which concern DP Manufacturing or associated shipping operations, if required.
• Maintenance of product integrity and company reputation by assisting in the monitoring of cGMP compliance at drug product contract manufacturers.
Education and Experience:
- BSc in Microbiology or degree in other technical discipline
- 5+ years of related experience in a Biotechnology or pharmaceutical cGMP environment preferred.
- Industrial experience with aseptic parenteral drug product filling operations.
- Previous experience of working with CMO’s an advantage
- Strong project management (PMP or equivalent), interpersonal, cross- cultural, communication, negotiation and problem solving skills qualification preferable.
- Technology Transfer experience an advantage.
For a confidential discussion and a more detailed job description (or more information on the role), please contact Donie Shine – firstname.lastname@example.org or call 0906478104.
For more information on our Recruitment and HR Services and to see a full list of our available jobs across Ireland, please visit our website www.collinsmcnicholas.ie
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