Analytical QC Manager
Our client, a blue-chip multinational healthcare manufacturer based in Galway, now seeks an Analytical QC Manager who will ensure that a team of chemists perform raw materials, finished products, non-routine and stability testing in accordance with GLP and cGMP.
The successful candidate will manage a team of supervisors and chemists overseeing all issues regarding; compliance, regulatory, technical investigation, test method optimisation, test method validation and technical transfers in the laboratory. Budgetary management experience is preferred.
Responsibilities of Analytical QC Manager:
Supervising and exercising functional control of the laboratory such that a compliant, cost-effective and efficient service is provided.
Final review and approval of all laboratory results, protocols, reports, SOPS etc.
Overseeing the analysis of finished product, in-process, R&D, validation samples and Stability Samples.
Provide technical guidance/ troubleshooting in the event of equipment failure, deviations or out of specification results.
Supervise analytical method validation, multi-site/lab method transfers and technical problem-solving.
Ensure that the product transfers meet the internal & external quality systems requirements in order to gain regulatory approval for launch.
Selection and recruitment of analytical staff in conjunction with human resources.
Conduct performance reviews of direct report.
Represent the laboratory on cross functional project teams as required.
Requirements of Analytical QC Manager:
Bachelor?s Degree in Analytical Chemistry or similar Chemistry qualification. Additional Masters or PhD would be ideal.
8+ year's analytical chemistry experience in FDA regulated environment.
2+ year's Lab Management / Supervisory / Team Lead experience is required.
Proven experience of HPLC (Waters Systems and Millennium software), GC, GC/MS, UV, FTIR, N-IR required in GCP / cGMP analytical laboratory.
Strong technical problem solving and troubleshooting skills.
Method development, validation and transfer experience.
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. Check out all our open jobs on our Recruitment website: www.rftgroup.ie
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Key Words; FDA, GMP, Lab Supervisor, Lab Manager, Analytical Lab Manager, Analytical Chemistry, HPLC, GC, UV, IR, Analytical Method Validation, Analytical Method Transfer, Pharmaceutical, Medical Devices, Galway, Clare, Connaught, Nationwide, Ireland.