Contract QC Team Leader

1 week ago


East London, South Africa Aspen Pharma Group Full time
Job title : Contract QC Team Leader (East London) Job Location : Eastern Cape, East London Deadline : December 18, 2024 Quick Recommended Links
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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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