QA Team Leader

3 days ago

East London, South Africa Aspen Pharma Group Full time

**Overview**

Interpret and implement quality procedures, standards and specifications for value streams. Manage and coordinate value stream QA activities. Coordinate and execute the review and approval of in-process quality programs. Manage and coordinate admin functions within quality systems. Performance management of direct reports and perform activities for process compliance and product release, when required.

**Responsibilities**

**Planning and Section Management**
- Provide technical and operational input on operational planning of the unit and on the prioritisation of objectives
- Provide input into budget and resource requirements of section
- Request and allocate assets and resources for the fulfilment of work objectives and monitor their use
- Provide section staff with day-to-day direction and tasks
- Run effective performance review meetings
- Attend L1-2 meetings
- Ensure visual performance boards are updated
- Completion and monitoring of time and attendance

**Product Release**
- Verify batch release conditions and documentation
- Manage and coordinate process to determine disposition of products
- Manage and coordinate batch release priorities in line with On Time In Full (OTIF) and planning schedule requirements
- Perform batch release when required

**Process Compliance**
- Issue, track and approve CAPA requests
- Manage implementation of operational changes to SOPs and processes
- Manage and coordinate process compliance activities to ensure that batch release is consistent with OTIF and planning schedule
- Leading deviations related to country requirements

**In Process Quality Management**
- Manage and coordinate in-process internal inspections

**Governance, Risk and Compliance**
- Monitor implementation and correct compliance with legislation, policies and procedures

**Skills Required**:
**Background/experience**
- Minimum of Bachelor’s degree (B Pharm)
- Minimum 4-6 years’ related work experience
- Pharmaceutical manufacturing experience

**Specific job skills**
- Strong working knowledge of pharmaceutical manufacturing and corrective action programs
- Pharmaceutical standards and compliance requirements
- People management
- Ability to interpret and implement policies, processes and objectives

**Competencies**
- Interrogating Information
- Managing Performance
- Planning and Organising
- Finalising Outputs

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