Kelly Services are currently recruiting a Senior Associate QA for our Global Biopharmaceutical client in Co. Dublin.
This an 1 year contract initially with an excellent rate on offer.
- · Perform all activities in compliance with safety standards and SOPs
- · Write, review and approve Sop's in accordance with Policies.
- · Provide Quality support for triage and investigation of all classes of non-conformance (NC) events.
- · Review and approval of NC1s and CAPAs for closure ensuring compliance with appropriate documentation, whilst ensuring that CAPA actions address root cause and implementation plan dates are achievable.
- · Participates in customer complaint investigations.
- · Provides training and advice to staff in order for them to perform their desired functions.
- · Observe and provide real-time quality oversight, and support for production unit operations
- · Review/approve production batch records, and associated documentation in preparation for Qualified Person disposition activities.
- · Review and approve cGMP records ensuring compliance with appropriate documentation.
- · Support continuous improvement and Operational Excellence initiatives.
- · Any other tasks/projects assigned as per manager's request.
Knowledge, Experience and Skills
- Third level qualification in Engineering or Science related discipline preferred.
- Relevant experience (4 yrs +) working in the pharmaceutical or biotechnology industry or other combination of experience and educational background. Excellent written and verbal communication skills.
- Experience working with dynamic cross-functional teams and proven abilities in decision making.
- Strong organizational skills, including ability to follow assignments through to completion.
- Demonstrated ability in problem solving and experience in managing Root Cause Analysis /Deviation investigations.
- Experience working in aseptic operations, protein formulation, vial and syringe filling.
- Knowledge of applicable Regulatory requirements, and ability to evaluate compliance issues.
Please apply today or contact Niall Curley on 086-4113572 for more information.
Kelly Services are acting as an Employment Business in relation to this role. Should you choose to apply, your information will be processed in accordance with Kelly's Privacy Statement. For information regarding data protection at Kelly, please visit the Kelly website and have a look into the Privacy Statement.
As an Equal Opportunities employer we welcome applications from all suitably qualified persons regardless of their race, sex, disability, religion/belief, sexual orientation or age.