LSC have a great contract opportunity for a QA Rep Supplier Management Supplier to join a Limerick based Biotech Drug Substance Manufacturing Facility.
This is an exciting opportunity to work with next-gen manufacturing technologies, advanced data collection and analysis platforms that will result in safety and quality improvements, increased productivity, and variability reduction.
If you have at least 3 years of relevant experience in a cGMP environment and ready for your next challenge, this could be the perfect project for you!
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Benchmarking of current and emerging initiatives in the specific Quality System(s)/Program.
- Own, review or approve change controls (including implementation steps), deviations (including tasks) associated with Supplier Management.
- Reports & escalates critical quality issues to the appropriate level of quality management for final resolution.
- Monitoring of GMP compliance, GMP programs & systems by ensuring a regular presence in the area of responsibility.
- Evaluation, audit and approval of 3rd party suppliers/contractors as appropriate for the area of responsibility.
- Contribution to the Quality plan for specific quality system/program initiatives.
- Maintains the vendor files for service providers, materials and consumables (generation of audit plans and Q agreements, assists in scheduling of local, national and international audits, manage vendor file periodic reviews as per local SOP, ensure all vendor file content is current and appropriately documented, monitor and modify the supplier evaluation process as required).
- Generate and maintain vendor files for materials (liaise with purchasing to define supply chain, complete risk assessments in conjunction with procurement and MS&T, participate in the new item code process, approval of material and vendor package, re-evaluation of vendors.
- Carry out day to day activities in compliance with site safety policy and procedure. Promote and encourage safe practices and promptly report any safety concerns.
- Assures consistent implementation of standards across the quality system.
- Maintenance of all aspects of GMP compliance for the area(s) of responsibility.
- Establishment, maintenance and management of a control system for the specific Quality System(s)/Program.
- Interpretation and application of emerging regulatory & GMP guidelines to the specific Quality System(s)/Program.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- BSc, MSc, or PhD in Biotech, Chemistry, Engineering or related discipline, with a minimum of 3 years relevant experience.
- Provide Quality leadership, direction and governance for the specific area of responsibility.
- Manage quality-related matters specific to area of responsibility
- Responsible for approving appropriate quality-related documents. Approval signature confirms that Lilly and GMP requirements have been met.
For our contracting positions in Ireland's pharmaceutical industry, applicants must possess a Stamp 1G or a Stamp 4 visa. We apologize for any inconvenience, as visa sponsorship is not available at this time. Thank you for your attention.
Apply via this advert or directly at Additionally please contact Jenny Murphy at 021 7318904 if you have any more questions about this opportunity!
