QA MANAGER - OPERATIONS
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Job Reference Number |
14568464 |
Client ID: |
RI/RFTA03747LOL |
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Posted On: |
Feb 13 2012 |
Location: |
GALWAY, CLARE, ROSCOMMON |
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Job Type: |
Permanent
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Salary: |
NEG |
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Benefits: |
- SUBSIDISED CANTEEN
- SHARE OPTIONS
- PENSION / PRSA
- BONUS
- PERM. HEALTH INSURANCE
- LIFE ASSURANCE
- RELOCATION PACKAGE
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QA Manager - Operations
to supervise 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.
Responsibilities of QA Manager - Operations
Supervision of; Quality Assurance Specialists and Quality Technicians.
Ensure Regulatory compliance in area of responsibility to cGMP’s.
Lead follow-up and completion of appropriate Corrective Actions from Complaint trends, inline with CAPA system.
Provide effective and responsive QA support to Operations to meet their area’s objectives of quality, cost and output.
Prepare monthly/Quarterly/yearly complaints reports.
Conduct Problem solving using Transactional Lean or Six Sigma tools, or similar structure problem solving techniques.
Manage Suppliers, both internal and external.
Manage Audit Issues, deal effectively with notified bodies.
Drive continuous improvements on all Quality issues.
Requirements of QA Manager - Operations
Bachelor's Degree in; Science, Quality or similar technical discipline.
8+ years' work experience in Quality Assurance environment, ideally GMP.
3+ 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 / larry@rftgroup.ie / 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, Engineering, Engineer, Quality, Quality Supervisor or Quality Manager, ISO9001:2000, Compliance, Product, 21CRF11, Validation, QP, Qualified Person, Complaints, Corrective Action, Pharmaceutical, Medical Devices, Limerick, Clare, Galway, Mayo, Midlands, Athlone, Nationwide, Ireland.