Job Description

OverviewDevelop, 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.ResponsibilitiesPlanning 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 units 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

Aspen Pharmacare