Job title : QC Team Leader (East London)
Job Location : Eastern Cape, East London
Deadline : December 18, 2024
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Description
Overview Manage and coordinate lab preparation and QC activities Manage and coordinate sampling and testing of external environment 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 prioritisation 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 QC Lab Testing 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 Environmental Management Manage and coordinate sampling and testing of external environment, according to SOPS and sampling plan/ schedule 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;
Requirements
Skills Required Background/experience National Diploma 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 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 Organising Customer Awareness
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