LSC have a great contract opportunity for a Senior QA Specialist - Compliance to join a Dublin based Biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines that can help patients overcome serious diseases and improve their quality of life.
If you have 2+ years industrial experience and are ready for your next challenge, this could be the perfect project for you Key Responsibilities: * Review and approve quality agreements.
* Release incoming materials for use in manufacturing operations * Support qualification of new suppliers/materials and requalification of existing.
* Assess supplier change notifications for impact to qualification status.
* Support material certification and direct dispense programs.
* Review and approve quality agreements.
* Authoring, review and approval of QA-related procedures.
* Support Op Ex programs and champion continuous quality improvement initiatives.
* QA review, assessment and approval activities for Biologics Manufacture, as applicable, for: o Change controls o Deviations/Investigations o CAPAs o Other associated documentation Qualifications & Experience BSc in Science or related discipline with a minimum of 2 years' Supplier Quality or related experience in a Biologics or Pharmaceutical environment.
A clear understanding of c GMP requirements for QA systems and compliance and/or manufacturing.
Detailed knowledge of Biologics Processing would be a distinct advantage.
Required to work on his/her own initiative in addition to working as part of a team.
Excellent communication, presentation, time-management and organizational skills are essential.
Employees are expected to display the BMS Biopharma Behaviours, which enable them to be successful and perform at their highest level.
Applicants interested in our contracting opportunities within the pharmaceutical sector in Ireland are required to have a Stamp 1 G or a Stamp 4 visa.
Please understand that we are unable to provide visa sponsorship.
Thank you.
Apply via this advert or contact Siobhan Cummins on 0 if you have any more questions about this opportunity Skills: Compliance Supplier Quality