QA Manager

5 days ago

Port Elizabeth, South Africa Aspen Pharma Group Full time

**Overview**

Develop, manage, and monitor quality procedures, standards and specifications for value streams in compliance with regulations. Manage and monitor core QA activities for value streams. Review and approve in-process QA programs and activities. Manage and guide the unit through team leaders. Performance management of direct reports and units.

**Responsibilities**

**Planning and Processes**
- Interpret, implement, and coordinate systems, processes, policies, and procedures contributing to the quality assurance in the unit.
- Provide input into existing systems, procedures and policies that impact in-process control activities in value stream operations and quality in the unit.
- Attend L2-3 meetings.

**Financial and Resource management**
- Provide input into the functional financial plan / budget based on operational requirements.
- Ensure availability and optimal allocation of resources within unit.

**People Management & Development**
- Implement human resource policies.
- Participate in training, coaching and development for team members.
- Develop and implement performance contracts and succession plans.
- Manage conflict, disciplinary and safety issues.
- Assist with recruitment.

**Product Release**
- Lot release and/or rejection of starting materials, packaging materials, intermediate, bulk and finished products.
- Review and approve process to release disposition of products.
- Determine batch release priorities in line with On Time In Full (OTIF) and planning schedule requirements
- Perform batch release when required.

**Process Compliance**
- Review and approve CAPA plans to address systematic issues
- Review and approve operational changes to SOPs and processes.

**In process Quality Management**
- Review and approve for in process quality management
- Ensure effective review and monitoring of supplier management system

**Governance, Risk & Compliance**
- Participation in management reviews and escalation of quality issues
- Ensure unit’s activities comply with operating guidelines and policies for the organisation and function.
- Monitor and correct compliance with legislation, policies and procedures to impact on the effectiveness of QMS.
- Review and approve document retention procedures

**Background/experience**
- Minimum of bachelor's degree (B pharm) preferred
- 7 years related work experience.
- Pharmaceutical manufacturing experience

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

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