Job Description:
Quality Control Lab Supervisor
Our client, a major employer in the Galway region have a requirement for an experienced Laboratory Supervisor to join them on a fixed-term contract.
This position will be based in the Stability and Technical Services laboratory. Working as part of a technical and stability team, you will be responsible for the supervising and exercising functional control of the analytical chemistry group such that a compliant, cost effective and efficient service is provided. The group has 10 people.
Key Responsibilities:
Control of stability chamber monitoring, schedules and testing.
Monitor and compile stability trends.
Liaise on an on-going basis with study owner on stability monitoring, ICH guidelines, new product status and communication from regulatory bodies.
Schedule product stability testing with Q.C departments in conjunction with SOPs and current regulatory guidelines i.e. FDA, MDD, ISO
Provide technical guidance/ trouble shooting in the event of equipment failure, deviations or out of specification results.
Assisting in the evaluation and validation of new methodologies and instrumentation.
Interacting with R&D and third party organizations in finalizing methods and transferring them to the site.
Creation of Analytical Procedures and Validation Protocols.
Training and development of laboratory staff.
Conduct performance reviews of direct report.
Represent the laboratory on cross functional project teams as required.
Skills, Experience & Qualifications:
A post graduate qualification in Analytical Chemistry or related discipline would be a distinct advantage. A BSc is a minimum requirement (HETAC Level 8)
2 years + as a Quality Control supervisor within the Pharmaceutical industry is required.
A knowledge of all current cGMP requirements is essential.
Complete knowledge of analytical method validation and subsequent transfer to other sites.
Thorough knowledge of analytical instrumentation and techniques.
Excellent interpersonal and communication skills with good leadership abilities.
Proven people management skills.
Experience working in an FDA environment is essential.
To apply for this opportunity please contact Maeve Lawlor in Brunel Recruitment on 051 309652 or email your cv to mlawlor@brunel.ie