Description : Contract Anlaytical Team Leader. Company : Aspen Pharma Group. Location : Port Elizabeth, Eastern Cape

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

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
• Bachelors 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 Organising
• Customer Awareness