Reference Number: JO-2109-475715
QC First Line Manager
Job Type: Permanent
MAIN DUTIES AND RESPONSIBILITIES
To operate the QC Analytical Services Laboratory in compliance with company safety policy and cGMP.
To manage and lead the QC Analytical Services Laboratory and to meet manufacturing deadlines.
Responsible for staff recruitment, appraisals and management to Policies and Procedures documents. Planning of staff work schedules, resource management and costing work programmes.
Utilising technical skills to validate specialised chemical and biochemical tests procedures to internationally recognised regulatory guidelines. Conduct problem solving investigations to resolve issues affecting Pharmaceutical manufacture.
Train staff within the QC Analytical Services Department in laboratory techniques and Quality Management Systems to GMP requirements. Assist staff within QC Analytical Services Department with their ongoing development to aid their career and personal progression.
Work with project teams and represent QC on these to contribute to the success of these business centres by delivering the required Analytical knowledge and services.
Play a lead role with both internal and external customers. Present the department and its operation to Regulatory Inspectors representing their respective national bodies.
Maintain an up to date awareness of regulatory and scientific developments via approved training courses and meetings that will contribute to the efficiency and effectiveness of laboratory working practices and aid personal development.
To ensure that clinical pharmaceutical products are tested from raw materials and in-process samples to finished products to demonstrate that they meet the specification prior to each batch release for administration to patients.
Ensure the stability program is successfully executed.
Maintain a programme of constant improvement.
Expenditure to financial limits.
Sign off authority for Pharmaceutical batch release tests
Review and approval of SOPs, Protocols and Risk Assessments.
Host audits both from internal and external parties
Write and review OOS investigations and deviation reports