Responsibilities
Planning & 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 & 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
- 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 process for in-process quality management.
Governance, Risk & Compliance
- 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.
Requirements
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 programs
- Pharmaceutical standards and compliance requirements
- People management
- Ability to interpret and implement policies, processes, and objectives.
Competencies
- Interrogating Information
- Offering Insights
- Managing Performance
- Planning and Organising
ATripleA Recruitment and Temps
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