Our client are a leading global pharmaceutical company dedicated to supporting customers and their businesses in ever better ways. With a presence in over 100 countries and over 10,000 employees, this organisation is one of the largest healthcare organisations in its defined sector. They are seeking an experience Quality Assurance Specialist / Consultant to join the Quality Operations team on-site in Wicklow on a 12-month contract basis. Competitive hourly rates
This position will report directly to the Site Quality Operations (QO) Lead and will serve as a partner to ensure compliance and execution of site operational activities and ensure the site is permanently inspection ready.
The QA Specialist - Operations will have responsibility for ensuring that the process for the manufacture of Active Pharmaceutical Ingredients is in compliance with cGMP and the associated regulatory requirements.
Duties and responsibilities will include:
- Provision of Quality oversight and support for Operations in the following key area/activities; manufacturing, testing, packaging and material management across all phases of development and commercial manufacture.
- Provide in plant/on the shop floor support and guidance for GMP product quality assurance and compliance for Manufacturing Operations, Laboratory Operations and Warehousing activities including but not limited to Batch Manufacturing and Analytical Testing, Deviations, Change Control, CAPA's and Training.
- Review /Approve Master Batch Record (MBR), Master Cleaning Records (MCR), Master Set Up Records (MSUR), Master Analytical Records (MAR).
- Quality reviewer of SOPs, EOPs, Change Requests, Protocols, Reports, etc.
- QA Release of Intermediates.
- Issuance of Batch Records and Cleaning Records
- Perform/Lead Internal Audits/Quality Walkthroughs
- Active participation in site Tier meetings
You should have skills and experience in the following:
- BSc and 4+ years experience in Quality, pharma/API/biologics preferred, with a current knowledge of cGMP's and regulatory guidance
- Success in developing, implementing and maintaining Quality Systems and Standards at manufacturing site level in accordance with ICHQ10 key principles
- Demonstrated knowledge and success in working with cross functional teams e.g. supplier management
- Ability to manage multiple projects simultaneously and prioritize work, goals and tasks in accordance with division and corporate objectives
To discover more about this opportunity, apply now or contact Maeve Fahey at HRM on +353 1 6321885 or for a confidential discussion.