Quality Assurance Specialist (Shift Work)
Our Bio-tech Client in Limerick are hiring! In this role you will have the opportunity to be responsible for providing QA oversight and support to manufacturing activities. The successful candidate will perform and lead activities in support of dispositioning product while ensuring compliance with Quality Assurance (QA) policies and procedures, cGMPs, SOPs, and our Clients Standard Requirement Documents.
- Provides QA oversight & support to manufacturing activities within the manufacturing areas to support:
- Issue resolution in conjunction with key stakeholders, including:
- Quality point-of-contact for troubleshooting and documentation of equipment/process/schedule disruptions
- Triage of potential non-conformances including securing necessary documentation for investigation team in real-time
- Support of/counter signing annotations
- Perform area walkthroughs
- Provide oversight and review of documentation for non-routine work such as Area in PAAS, Incursions, Changeover
- Support Inspection readiness
- Support SOP/Manufacturing Record review for usability and fitness for use
- Participate in shift huddles to provide QA observations and QA perspective on containment for ongoing operations and activities
- Perform and lead consultation or advice in alignment with QA policies
- Represent Quality Assurance in support of complex and/or significant Deviations, Change Controls, APAs, 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
- Perform activities associated with disposition of product (e.g., manufacturing record review, document review, etc.)
- Review, edit, or approve controlled documents
- Review and approve investigations associated with product or processes
- Continually evaluating processes and procedures with an eye toward continuous improvement
- An understanding of biologics manufacturing operations
- Good organizational skills and attention to detail
- Good written, verbal and interpersonal communication skills and the ability to effectively interact cross functionally
- The ability to prioritise multiple assignments and changing priorities and meet deadlines
- An ability to learn and utilize computerized systems for daily performance of tasks
- To be considered for this opportunity you should have a BS/BA in a scientific discipline or related field and minimum 2 years relevant experience. Relevant experience may be substituted for education requirement
For further information on this role in please contact Mark Wilson on 0860449473 or email email@example.com
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