Senior Quality Assurance Specialist

Sigmar Recruitment

South Dublin

The QA Specialist will typically report to a QA Senior Manager and will be required to be a Subject Matter Expert in their assigned area of responsibility.  In addition to routine Quality Assurance duties, QA Specialists may be assigned specific oversight and responsibilities for key quality systems or processes and may also serve as a primary quality partner/point of contact for functional areas. Responsibilites: Perform all activities in compliance with safety standards and SOPs. Provide Quality direction and input at Change Control and NC Review Boards and assume oversight of change control and NC/CAPA records; ensuring scope of record is clear and implementation activities are robust and timely. Write, review and approve Standard Operating Procedures. Participate in site activities associated with QMS programs (e.g., Validation, Complaints, Change Control) and provide active input into shaping the future direction of these systems. Review and approval of NCs and associated 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. Incoming QA & Disposition Function (may perform some or all of these duties. Provide overall quality direction and oversight for key functional areas including the Warehouse, Supply Chain, Sampling activities, and the inspection and testing of incoming materials. Act as Quality point of contact and decision maker for investigations, change controls, and other associated quality related activities. Site Program Owners for site disposition activities, Quality Agreements, Site Master File, Market Action activities and for the provision of subject matter expertise for related programs including, Complaints, Stability and Product Quality Review. Co-ordinates and approves the preparation of reports for Product Quality Reviews including batch listing and deviation trend reports to ensure that trends are acted upon and to demonstrate that products consistently meet desired critical quality attributes. In line with business requirements, these responsibilities may expand or otherwise include additional areas of responsibility which are not described in this specification but are associated with the role. Qualifications: University degree. Engineering or Science related discipline preferred. Relevant experience (8yrs +) 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 / Non Conformance /Deviation investigations. Detailed Knowledge of applicable Regulatory requirements. Experience with Regulatory inspections. Experience working in aseptic operations, protein formulation, vial and syringe filling.

1191 days ago