Role Responsibilities:
- Oversee the management of the Global Change Management process at the site as well as drive best practices, and harmonisation of the Trackwise process to ensure the relevant procedures and best practices are applied in the creation, approval and execution of Trackwise records.
- Ensure the health & wellbeing of the system at the site to ensure timely actions are taken to meet compliance & production needs
- Support SME’s for the various change types (e.g. automation, equipment, process),
- Support Regulatory and Compliance Inspections at the site with the support of the change type SME’s as needed
- Provide guidance to site Users.
- Approval and maintenance of user access and submission of User Access Request forms as well as, when necessary, review, approval and submission of Selection Value Requests & TR Reset Requests
- Generation of metric data for Site Leadership review and awareness
- Ensure the timely completion of annual user access verification
- Cross train with some key QMS support activities including documentation management overview.
Role Requirements:
- Bachelor's degree (or higher) in Chemistry, Biology, Microbiology, Automation, Engineering or equivalent
- Previous experience in in Quality Assurance/ Quality Systems
- Excellent knowledge of relevant Quality and Compliance Guidelines (Quality Management Systems, cGMP, Change Control) and respective regulations.
- The motivation to be an inspiring member of a high performing team.
- The passion to build the future of MSD Biotech Dublin
- The desire to continuously learn, improve and develop
- A great communicator, decisive decision maker and proven ability to deliver excellence
- Confidence to direct off-site suppliers to the project, willingness to support the team and a lazer light focus to deliver excellence
- Strong contemporary knowledge of relevant cGMPs, regulations and current industry trends.
- Experience with new product introductions and/or process qualification/technology transfer
What’s in it for you:
- Stable contract duration
- Competitive hourly rate