Analytical Team Leader - Port Elizabeth
Aspen Pharma Group
Job purpose Manage and coordinate validation testing to support tech transfers. Manage and coordinate laboratory specifications & testing methods. Provide analytical, maintenance and QC lab support. Ensure continuous compliance of lab with GMP standards. Ensure that products are produced, tested and stored according to the required SOP’s and documentation. Performance management of direct reports. Responsibilities Planning and Section Management Provide input into operational planning of section, and prioritization of objectives. Provide input into, interpret and execute policies and procedures. Provide input into and manage budgets and resource requirements for section. Provide section staff with day-to-day direction and tasks. Validation testing to support technology transfers. Manage and monitor compliance of QC lab testing activities to GMP, quality standards, and product specifications. Manage and coordinate lab preparation activities according to SOPs (samples, working area(s), PPE and lab equipment) Prepare and implement maintenance and calibration schedules and records. Ensure set priorities and targets are achieved, identifying constraints and solutions. Investigate and report Out of Specifications (OOS) Enforce Good Lab Practice Specification upgrade and maintenance Manage and coordinate specification preparation, upgrade and maintenance projects according to SOPS and project plans. Lab Quality Reviews & Training Validate batch documentation approvals. Review and approve corrections in batch documentation. Identify and coordinate training of staff on SOPs. Deviations Investigations Manage and coordinate deviation investigations and reporting. Coordinate and initiate risk/ impact assessments and plans to address quality deficiencies. Manage implementation of operational changes to SOPs and processes. Governance, Risk & Compliance Provide input to QC for improvement of risk-based compliance systems. Monitor implementation and correct own and/or team compliance with legislation, policies and procedures. Skills Required Background/experience Bachelor's degree in chemistry or microbiology with 5 years’ related experience Laboratory and Good Laboratory Practice experience Supervisory experience Specific job skills Advanced understanding of pharmaceutical testing methods and analytical method verification / transfer testing Knowledge of value chain and MCC principles Understanding of pharmaceutical manufacturing and corrective action programs Pharmaceutical standards and compliance requirements Ability to interpret and implement policies, processes and objectives. Competencies Interrogate Information Managing Performance Planning and Organizing Customer Awareness
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