Description:
BMS External Manufacturing is looking to recruit a permanent Contract Senior Manager, Qualified Person, reporting Associate Director, QP Lead Global Quality, to join the team for certification of externally manufactured sterile and non-sterile finished pharmaceutical products to be released to the EU/EEA and ROW markets
Key Duties And Responsibilities
- EU QP Certification of non-Sterile and Sterile pharmaceutical products for the EU/EEA and ROW markets which have been manufactured and checked in accordance with its marketing authorization, the principles and guidelines of GMP as laid down in Directive 2003/94/EC and other relevant legal requirements
- Continually maintain familiarity with the manufactured and tested requirements specified in the Market authorisation, national legislation or cGMPs for all products under their remit as per the MIA. .
- Guidance and support of the Quality Operations teams to support batch certification activities.
- Actively support the BMS Fact Finding Investigation Teams (FIT), Fact Finding review Meetings (FIRM) and Product Review Committee (PRC) processes for investigations.
- Collaboration with launch excellence and other functional areas to support new product introductions and new market launches
- Participate in regulatory and corporate audits as required.
- Participation in the product recall process and Competent Authority notification process.
- Undergo continuous professional development including self- study, site visits, internal and external training courses to keep abreast of current trends in manufacturing technology, GMP and regulatory affairs.
Qualifications, Knowledge And Skills Required
- Leadership and communication skills.
- Proficient communicator and collaborator at a variety of levels.
- Proven success working well in a team environment with flexibility to react to changing business needs.
- Demonstrated problem solving and project management skills.
- Direct experience in interfacing with external manufacturers
- Educated to a degree level in science, engineering or related discipline with extensive experience in the biopharmaceutical/ pharmaceutical industry.
- The qualified candidate must have the qualification and experience to be eligible to act as a QP in Ireland on an MIA issued by the HPRA as specified in the Medical Products (Control of Manufacturing) Regulations 2007 S.I. No. 539 of 2007.