As this is a role in biotech, it is particularly suitable for pharma experts seeking to break into biopharma. It’s a 12-18month hourly-paid contract, at very attractive rates.
The Quality Assurance (QA) Specialist is a senior and active role within the broader QA function.
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. QA specialists will be required to understand and grasp a broad range of quality related competencies.
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 including Supply Chain, Information Systems, Manufacturing, Process Development, Validation, Engineering and Quality Control.
Successful candidates will typically be educated to degree level in a Scientific or related discipline and ideally will have acquired technical skills and demonstrated competencies across a broad range of quality related disciplines. QA Specialists may be cross trained and/or assigned additional project specific duties, including continuous improvement/operational excellence initiatives.
• 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 in accordance with 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
• Participates in customer complaint investigations.
• Provides training and advice to staff in order for them to perform their desired functions.
• University degree. Engineering or Science related discipline preferred.
• 8yrs + (3+ in Quality Assurance) working in the pharmaceutical or biotechnology industry or other combination of experience and educational background that may otherwise satisfy the requirements of the role.
• QP qualification is a strong plus. This role sits at QP / Manager – equivalent level within the organisation
• 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.
If you would like further Information you can contact the recruiter directly:
Brian Christensen | Tel: +353 (0) 1 685 4747