Qc Analytical Team Leader

1 week ago

East London, South Africa Aspen Pharma Group Full time

**Overview**
- 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
- 5 years’ related experience in 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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