Our client, a leading pharmaceutical company based in Limerick currently has a great opportunity for a Senior Quality Specialist to join their growing team. This is a full-time, permanent position offering an excellent salary and benefits package.
Summary: Performs and leads activities in support of dispositioning product and/or raw materials while ensuring compliance with Quality Assurance (QA) policies and procedures, cGMPs, SOPs, and Standard Requirement Documents.
Essential Duties and Responsibilities
Represent Quality Assurance in support of complex and/or significant Deviations, Change Controls, CAPAs, etc., including active participation in investigation, evaluation, and problem resolution,
Represents the IOPS organization on behalf of QA with external partners to communicate IOPS QA policy and procedures; liaise with external partners and provide input on regulatory communications.
Train and/or mentor employees, including providing insights and education on processes and procedures, and conveying expectations of QA organization;
Provides consultation or advice in alignment with QA policies;
Perform activities associated with disposition of raw materials and product (e.g. manufacturing record review, receipt, inspection, document review, shipping, etc.). Activities may be on the floor or at a desk
Review, edit, or approve controlled documents
Review and approve investigations associated with raw materials, product, laboratory, or facilities.
Perform status labelling of raw materials and product
Education and Experience:
Requires BS/BA in scientific discipline or related field and minimum 5 year relevant experience.
Relevant experience may be substituted for education requirement.
Understanding of biologics manufacturing operations is preferred.
Ability to stand for periods of time when performing tasks on the floor.
Ability to work a varied schedule including off shift and weekends
. For more information on this position please call Rachael O’Rourke on 061336136, alternatively apply online and a member of the Harmonics team will be in touch