Quality Operations Lead, Galway
required to lead a team of QA Specialists on product complaints and maintain quality systems for Customer Complaints, dealing with Quality issues on a number of Production lines and in accordance with CAPA system.
The successful candidate will develop and oversee QA team in conducting problem solving using Transactional Lean or Six Sigma tools, or similar structure problem solving techniques within operations environment.
Responsibilities of Quality Operations Lead:
Supervision of; QA Specialists and Quality Technicians.
Provide effective and responsive QA support to Operations to meet their area's objectives of quality, cost and output.
Lead follow-up and completion of appropriate Corrective Actions from Complaint trends, in line with CAPA system.
Ensure Regulatory compliance in area of responsibility to cGMP's.
Prepare monthly/Quarterly/yearly complaints reports.
Manage Suppliers, both internal and external.
Manage Audit Issues, deal effectively with notified bodies.
Drive continuous improvements on all Quality issues.
Conduct line management duties including; motivating staff, performance reviews, setting goals and objectives, hiring staff.
Requirements of Quality Operations Lead:
Honours Bachelor's Degree in; Science, Quality or similar technical discipline.
8+ years' work experience in Quality Assurance environment, ideally GMP.
2+ years' line management experience.
Proven experience in FDA or notified body audits essential, with previous experience of CAPA systems.
Qualification / training in Six Sigma is highly desirable.
Please contact Larry on 01-2302400 / firstname.lastname@example.org / www.rftgroup.ie
The RFT Group, Biopharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors.
Key Words; FDA, GMP, Quality, Quality Supervisor, Quality Assurance Manager, Compliance, Validation, QP, Qualified Person, Complaints, Corrective Action, Pharmaceutical, Medical Devices, Limerick, Clare, Galway, Mayo, Nationwide, Ireland.