Job Opportunities in South Africa
September 14, 2024
Aspen Pharma Group
East London
FULL TIME
QC Team Leader
Overview
Planning and Section Management
- 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
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
- 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
- Manage and coordinate sampling and testing of external environment, according to SOPS and sampling plan/ schedule
- Validate batch documentation approvals
- Review and approve corrections in batch documentation
- Identify and coordinate training of staff on SOPs
- 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
- 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
Background/experience
- National Diploma in Chemistry or Microbiology with 5 years’ related experience
- Laboratory and Good Laboratory Practice experience
- Supervisory experience
- 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
- Interrogate Information
- Managing Performance
- Planning and Organising
- Customer Awareness
We regret to inform you that this job opportunity is no longer available
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