Authority, Responsibility, Duties & Competence Requirements

Job Purpose: To ensure total compliance of the department to pharmaceutical GMP standards and support production activities from a pharmaceutical perspective.

Responsibilities / Duties

• Responsible for the assessment of production processes in order to establish level of compliance versus pharmaceutical standards.
• Promotion of GMP Compliance within the department.
• Conduct product anomaly investigations and complete CAPA actions report to prevent re-occurrence of anomaly incident. Ensuring timeous close-out of events/deviations, CAPAs and change controls.
• Responsible for the recipe creation, implementation and recipe maintenance.
• Performs departmental internal audits to establish level of compliance and necessary corrective actions to close gaps identified.
• Participates in external departmental audits and the completion of the subsequent au...