About The Role

• The role of Operational quality analyst (OQA) is meant to ensure Shift-based oversight of facilities, equipment and personnel to ensure real-time compliance to procedures, instructions, contemporaneous data integrity and other cGMP requirements, including participation in Rapid Response approach to address deviations, with Operations, Engineering and Technical to ensure finished product and intermediate products meets quality requirement at the time of Processing
• The role holder will support the batch release pharmacist to ensure that GMP is enhanced throughout Batch processing cycle and to support batch release by ensuring processes are under control for quality critical attributes
• The role of the OQA as First Line Leader is to develop and enable a first touch team of operators to consistently deliver outstanding safety, quality, service and value to the person at the end of our supply chain’. The role has a direct hour by hour impact on the ambition of the GMS Strategy to achieve zero Defects

Key Responsibilities

• Carry out continuous in process inspection for the product during production processes, and ensure all parameters are within specification
• Coaching operators/technicians on GMP requirement, quality issues and ensures non-compliances to GMP are addressed in timely manner by working with line manager, quality and technical team
• Identify areas to drive out operational waste and cost reductions thereby optimizing the Manufacturing and packaging processes
• Make detailed observations, analyze data, and interpret analytical result. Manage towards, and report monthly against Quality KPI targets
• People Leadership – full people leadership for a team of staff working within a production environment
• Conduct effective risk assessments
• Support Product releases

Required

Qualifications and skills

• The job holder should have a degree in Pharmacy (Registered with Pharmacy and Poisons Board).
• Minimum 2 years’ experience in a similar role with proven track record in achieving results.
• Manufacturing experience/background preferable pharmaceuticals and/ or FMCG organizations.
• Experience in multi-product operations.
• Experience with people management.

Other Skills/Qualifications

• Excellent interpersonal and facilitation skills
• Analysis and Problem Assessment
• Planning and Organizing
• Desire and ambition to Improve Systems and Process
• Strategic Thinker: ability to think outside the box
• Quality Auditing