The QC COE lead is a specialised critically important role within the QC organisation to ensure efficient and effective compliant design, construction, qualification, and operation of a new facility. This tremendous opportunity 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 QC labs.
- The motivation to be an inspiring member of a high performing team.
- The desire to continuously learn, improve and develop.
- A great communicator, decisive decision maker and proven ability to deliver excellence.
- Strong knowledge and experience of validation methodology.
- 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 MSD 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.
- Degree qualification (Science/Quality/Technical).
- Desirable evidence of Continuous Professional Development.
- Preference Lean Six Sigma
- 5-7 years industry experience with significant knowledge and experience in laboratory instruments, validation and life cycle.
- Validation knowledge
- Problem solving skills.
- Leadership skills.
- Ability to respond to changing priorities.
- Communication skills.
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