QA Specialist - Operational Excellence
- Dublin
- Contract
- Full-time
- Responsibility and oversight for the development and maintenance of site quality systems, quality compliance and related procedures and processes, including but not limited to, Documentation Management, Change Control, Deviation/CAPA processes, oversight of applicable QMS systems supporting and the overall Quality Management Review process.
- Provide Quality direction and input at Change Control and Deviation Review Boards and assume oversight of change control and Deviation/CAPA records; ensuring scope of record is clear and implementation activities are robust and timely.
- Oversee and implement Quality Agreements relating to area of responsibility.
- Keep abreast of regulatory initiatives and new guidance/requirements and for the communication of revised guidelines associated with company Quality Systems.
- Responsible for sustained compliance initiatives, including execution of gap assessments in support of revised operating Standards and/or corporate policies & procedures.
- Oversight and management of Quality Risk Management (QRM) Processes and for the embedding of QRM principles within the quality framework.
- Ownership, accountability and provision of Subject Matter Expertise for key quality Systems, including Change Control, Deviation/CAPA processes and Documentation Management.
- Responsible for trending programs associated with Deviation/CAPA, Change Control, Complaints, Periodic Reviews, QRM, ensuring that trend programs and outputs are providing key indicators as to program efficacy.
- University degree. Engineering or Science related discipline preferred.
- Relevant experience (5yrs +) working in the pharmaceutical or biotechnology industry or other combination of experience and educational background that may otherwise satisfy the requirements of the role.
- 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.
- Detailed Knowledge of applicable Regulatory requirements. Experience with Regulatory inspections.
- Experience working in aseptic operations, protein formulation, vial and syringe filling.