Quality Manager for Finished Product
to oversee the QA functions of in-process product quality checks, AQL Inspection, Product Sample Retention, Periodic Product Review, Batch Documentation Review, Product Release and Batch Documentation Archiving in line with cGMP.
Responsibilities of Quality Manager for Finished Product:
Supervise the QA review of batch records for release of product, in line with Marketing Authorisation Compliance and European Product Compliance.
Supervise the QA inspection of bulk and packed product during processing and packaging operations.
Supervise the QA inspection of all packaging components, manage release system, report data relating to supplier's performance, work with packaging suppliers on continuous improvement projects which enhance the supplier's performance.
Review Manufacturing Investigation Reports, Packaging Specifications and product & component defect classifications, in line with company procedures
Requirements of Quality Manager for Finished Product:
Bachelors Degree in Science or related technical degree.
8+ years experience in a pharmaceutical / biopharma product release manufacturing company.
2+ years supervisory / management experience in GMP environment.
Identifying and implementing appropriate corrective & preventive actions.
Investigation/Audit commitments within Quality group area of responsibility.
Six Sigma qualification / training are highly desirable.
Please phone 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, Quality Assurance, Quality Specialist, QP, Quality Engineer, Compliance, Product, Production, Manufacturing, 21CRF11, Validation, Complaints, Corrective Action, DOE, Pharmaceutical, Medical Devices, Galway, Clare, Munster, Connaught, Nationwide, Ireland.
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