Role: QA Specialist-Batch Release
This company offers a unique, world-class opportunity for interested candidates. It has been consistently ranked a “Top Employer” in Science Magazine’s rankings for pharmaceutical and biotechnology companies. It is fully committed to bringing its award-winning approach to its subsidiary in Ireland, and is looking for outstanding people who are excited by a start-up environment, recognize the opportunities that this offers and wants to be challenged.
Summary:Performs activities in support of dispositioning product while ensuring compliance with Quality Assurance (QA) policies and procedures, cGMPs, SOPs, and the companies Standard Requirement Documents.
Essential Duties and Responsibilitiesinclude, but are not limited to, the following:
• Responsible for preparation & review of batch disposition documentation to support QP release of Formulated Drug Substance. Activities include but are not limited to;
- Review of QC related release data
- Documentation review
- Compilation of deviation, change control & batch record reports to support disposition
• Perform status labelling of product as required
• Represent Quality Assurance in support of deviations, CAPAs, etc., as required
• Provides consultation or advice in alignment with QA policies
• Review, edit, or approve controlled documents
• Interacts with various departments to ensure batch release deliverables are met
Knowledge, skills, and abilities:
• Understanding of biologics manufacturing operations is preferred
• Excellent organizational skills and attention to detail essential
• Requires good written, verbal and interpersonal communication skills and the ability to effectively interact cross functionally.
• Ability to handle multiple assignments and changing priorities.
• Ability to learn and utilize computerized systems for daily performance of tasks
• Ability to prioritize, manage multiple tasks, and meet deadlines
Education and Experience:
• Requires BS/BA in scientific discipline or related field and minimum 3 year relevant experience. Relevant experience may be substituted for education requirement.
This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about this company’s unwavering commitment to combining good science & good business.
If you would like further Information you can contact the recruiter directly:
Libby Ryan | Tel: +353 (0) 1 507 9254