Senior QA Specialist - 90-100k
Our client, a top Pharmaceutical company in Dublin, is seeking an experienced QA Specialist to join their growing team. This exciting position is an initial 1 year contract offering a generous hourly rate!
The QA Specialist will be responsible for key quality systems or processes and may also serve as a primary quality partner/point of contact for functional areas within ADL, including Supply Chain, Information Systems, Manufacturing, Process Development, Validation, Engineering and Quality Control.
- Provide Quality direction 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 in accordance with company policies.
- 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
- Provide training and advice to staff, in order for them to perform their desired functions.
- 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.
- Review and approve validation lifecycle documents, including Master-plans, protocols, reports and active participation during earlier phases of process design, Characterisation, Commissioning etc.
- 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.
- Level 8 degree - Engineering or Science related discipline preferred.
- 7-8 year's relevant experience working in the pharmaceutical or biotechnology industry or other combination of experience and educational background that may otherwise satisfy the requirements of the role.
- Experience working with dynamic cross-functional teams and proven abilities in decision making
- 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 in NPI, Sterile Manufacturing and Vile and Syringe Product Introduction would be a distinct advantage
For a confidential discussion or further information, please call Emer on 0860437889