Truly global Pharmaceutical Company seeks an experienced QC Manager, to direct and control the Formulation Quality Control team activity in line with Operational GMP, MRP and Regulatory requirements.
Duties may include:
Organises the routine activities of the Product testing Teams to meet operational requirements. Product Teams covered are Raw Materials, Pharmaceutical and Microbiological. Maintains clear communication with Product Team leaders and Senior Analysts and the management team. Approval of Laboratory and Production documents, this includes: Calibration, OOS investigation procedures and Validation documents. Verifies laboratory data and ensures accurate primary records are kept. Ensure processes are suitable to receive, disposition and book raw materials, intermediates and in-process materials. Controls and manages the Product Groups workload in conjunction with relevant team leaders and Senior Analyst. Lead Team Leaders and Senior Analysts in the identification of training required for product team members and develops training plans. Performs appraisals and identifies development plans for product team leaders. Identifies and coordinates laboratory recruitment. Ensures adherence to company safety standards and policies and maintains good industrial relations in an environmental of change. Ensures that all instruments are calibrated and adequately maintained prior to use. Maintains GLP and ensures laboratory activities associated with the products in the bench area, meets the requirements of MHRA, FDA and customers. Approves laboratory investigations with product team leaders and creates action plans Monitors failure / change for documentation required for the product testing groups. Keeps abreast of new analytical techniques and equipment as appropriate. Undertake projects, impact goals and specific responsibilities as required by Site Head of Quality To be work centre manager for the planning and control process. This includes Capacity planning, dispatch list review, ADR generation, Sales and operation planning process, Performance measures and routings. QA Manager level access in SAP. Makes technical decisions regarding the validity of analyses. Makes decisions and approves strategies around failure investigations Recruits and deploys staff to carry out the tasks required in the priority required, determining movement of staff to different areas of business Manages priorities to ensure that the important tasks are achieved within the appropriate time frame. Determines the urgency required for resolution and elevation of any issues resulting from the testing programme.
Skills & Experience:
Relevant Technical experience, science graduate or equivalent with experience working in an analytical laboratory. Performance management Conflict management Recruitment Absence management Knowledge and understanding of the laboratory and site operations