Job Description
required to supervise a team of Chemists while overseeing the analysis of finished product, in-process, R&D, validation samples and Stability Samples are performed in accordance with ICH / GCP, cGMP and FDA requirements.
The successful hire will lead a team of Chemists, including the selection and recruitment of Chemists, training and development of Chemists and conducting performance reviews of direct report.
The ideal candidate will be experienced Chemistry Supervisor in the areas of cGMP, Compliance, Regulatory, Technical Investigation, test method optimization, test method validation and technical transfers in the laboratory.
This is a permanent role based in Galway.
Responsibilities for Analytical Chemistry Supervisor:
Represent the laboratory on cross functional project teams as required.
Attend and represent the Analytical Laboratory at various meetings as required and communicate the required information as required.
Supervising and exercising functional control of the laboratory such that a compliant, cost effective and efficient service is provided.
Supervision of method validation and analytical technical transfers from donor sites.
Final review and approval of laboratory results, protocols, reports SOPs, etc.
Provide technical guidance/ trouble shooting in the event of equipment failure, deviations or out of specification results.
Drive continuous improvement within the laboratory in terms of Quality, Compliance and Efficiency using tools such as LEAN and Six Sigma.
Requirements for Analytical Chemistry Supervisor:
Bachelor's Degree in Analytical Chemistry or similar Chemistry qualification. Additional Masters or advanced qualification would be ideal.
6+ year's QC Chemistry experience in FDA regulated environment.
2+ year's Lab Supervisory or Team Lead experience is required.
Proven experience of HPLC, GC, UV, FTIR, N-IR required in GCP / cGMP laboratory.
Proven analytical method development, validation and transfer experience.
Please phone Larry on 01 - 2302400 / larry@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. www.rftgroup.ie
Follow us on: Facebook, Linked-in, twitter
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.