Description
My Client is a Leading Biotechnology company based in Dublin, Is seeking a Senior QA Specialist.Responsibilities include:
-Liaising with cross functional and network functions to ensure robust nonconformance or product complaint investigations are completed.
-Developing and managing the implementation of investigation plans for nonconformance's or product complaints
-Identifying and coordinating an investigations team to include all internal and external key stakeholders and subject matter experts necessary for a complete investigation.
-Collaborating with Regulatory, Qualified Persons and Quality Sciences to determine regulatory reporting requirements for nonconformance's or product complaints.
-Leading investigations teams to identify actionable root causes and robust CAPA by effectively utilizing advanced root cause analysis tools (Causal Factor Analysis, Kepner-Tregoe, etc.).
-Documenting thorough and well written investigation reports in the applicable database for non-conformances and product complaints.
-Providing timely and comprehensive investigation status updates to senior management
-Creating presentations of investigation summaries for Executive Management review board.
-Participation in regulatory inspections and defending nonconformance approach and rationale.
-Any other duties that may be required as directed by line manager.
Requirements:
-Bachelor's degree and 8 years of directly related experience
-Advanced degree is desirable
-Expertise with TrackWise or similar database in supporting Nonconformance investigations, CAPA, Change Control, Complaints
-Demonstrated experience participating in, managing, and responding to corporate audits/regulatory inspections
-Expert awareness of cGMP requirements for NC Investigations and CAPA
-Excellent written and verbal communication skills, ability to work in a team matrix environment and build relationships with partners
-Application of project management principles and techniques
-Good understanding of cGMP and regulatory requirements with proven ability to influence and guide discussions and decisions.
-Demonstrated ability with project management, initiating and leading cross-functional teams
-Strong knowledge of and experience with processes involved in API and drug product manufacturing, Quality Assurance, and Quality Control.
If you are interested in this great opportunity please contact me Anna Mooney or apply below with an upto date CV. Sthree UK is acting as an Employment Agency in relation to this vacancy.