Technical Services Manager required for a global biotech based in North Dublin.
Technical Services Manager required for a global biotech based in North Dublin. This a fantastic opportunity for you to be involved in this companies first ever large-scale mammalian-based Drug Substance facility.
You will be responsible for all instrumentation across all labs, software systems; validation of instrumentation; instrumentation life cycle; instrumentation maintenance and calibration program; the stability program other supporting activities that go across all Quality Control labs.
- Strong knowledge and experience of validation methodology, technical transfer and instrumentation setup
- Understand the maintenance and calibration program for all of the QC labs.
- Ensure all QC instrumentation meets the currently requirements and monographs.
- Has a good working knowledge on IT system and their interactions with lab instrumentation.
- Ensures data integrity requirements is verified and maintained for the life of the instruments.
- Strong knowledge on a stability program.
- Delivery of area performance to meet or exceed performance or quality goals.
- Ensure compliance with cGMP and other business compliance regulations.
- Promote and participate the implementation and maintenance of the relevant safety programmes.
- Participate in risk assessments, inspections, audits, incident investigations, etc. and implement and follow-up on corrective / preventative measures.
- Participate and Comply with the Quality Management System requirements.
- Build relationship with IT, site engineering and vendors.
- Good understanding on how to build good relationships with key partners, (external vendors etc.
Education & Experience required:
- 5-7 years industry experience with significant knowledge and experience in laboratory instruments, validation and life cycle.
- Degree qualification (Science/Quality/Technical).
- Validation knowledge
- Technical knowledge
- Scientific qualification and relevant experience in pharmaceutical environment
- The motivation to be an inspiring member of a high performing team.
- A great communicator, decisive decision maker and proven ability to deliver excellence.
Morgan McKinley is acting as an Employment Agency in relation to this vacancy.
Please note that any references to salary or pay rates in this advertisement and in the salary refinement section are indicative only and should only be used as a guide.