COMPETENCIES:

• Good time organisation skills
• Strong team working ability
• Good communication skills
• High level of attention to detail
• Good problem solving skills
• Good decision making skills

• Prepare GMP batch records for use in GMP manufacturing processes.
• Review, approve, and issue manufacturing documentation.
• Determine scale-up criteria from development to manufacturing scale.
• Generate process mass balances and flow diagrams.
• Identify, design and define large scale manufacturing equipment.
• Define materials for use in a GMP manufacturing environment
• Generate quality documentation for raw materials and equipment.
• Work within the Piramal quality system to initiate, manage and evaluate requests for change.
• Perform investigations, close CAPA’s and deviations.
• Project manage all aspects of the introduction of processes to manufacturing.
• Perform risk assessments in alignment with ICH 9Q.
• Evaluate process materials for suitability for use in manufacturing.