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 audit finding report. Conduct ad hoc product studies or trials as part of process i...