16671-QA Specialist- Dublin Contractor

This is a 11-month contract.

Purpose:

The Quality Assurance Specialist – QMS Change Control is responsible for active contribution to and maintaining of the Change Control Trackwise System. Interaction with cross-functional depts on-site in addition to engagement with the above Site groups will be a key part of the job.

Responsibilities:

• This position will include a combination of the responsibilities listed, primarily acting as the Site’s change control Subject Matter Expert and overseeing the use of the system:
• Oversee the management of the Global Change Management process at the site as well as drive best practices, and harmonization 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 & well being of the system at the site to ensure timely actions are taken to meet compliance & production needs
• Support SMEs 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 SMEs 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

Minimum Qualifications & Requirements:

• Bachelor’s degree (or higher) in Chemistry, Biology, Microbiology, Automation, Engineering or equivalent.
• A minimum of 5-7 years of experience in Quality Assurance/ Quality Systems
• Excellent knowledge of relevant Quality and Compliance Guidelines (Quality Management Systems, cGMP, Change Control) and respective regulations.
• 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.