To ensure total compliance of the department to pharmaceutical GMP standards and support production activities from a pharmaceutical perspective.
§ 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 improvement initiatives.
§ Participates in writing, reviewing and updating departmental Standard Operating Procedures.
§ Coordinate/Conduct training initiatives within the department to ensure that all staff is properly trained and competent to perform their job function.
§ Responsible for the identification of process improvement opportunities in order to prevent product loss and unnecessary product discard.
§ To take on mentoring role for pharmaceutical staff.
§ Responsible to perform investigations in the area of responsibility, with the support of the tool Kabitrack
Occasionally perform duties of Production Pharmacist as follows:
§ Ensures that his/her supervisors/team leaders are conversant with daily production program and organizes the department’s activities accordingly.
§ Identifies and addresses daily production problems
§ Reports / liaises daily with the Department Manager on the production situation.
§ Performs department pharmaceutical duties.
§ Is responsible for department productivity and loss control (labour, money, machines)
§ Ensures that the daily production program and targets are met.
§ Carries out ‘second line’ management function for staff problems/disputes.
§ Responsible for the department compliance with factory rules and regulations.
§ Responsible for the accurate completion and reconciliation of departmental batch book documents
§ From time to time carry out other jobs within the department / factory, which are consistent with the grade, qualification and training of the incumbent
§ Understand LVP production processes
§ GMP Principles
§ Understand quality investigation requirements (risk assessments, deviations, change controls ie. Kabitrack)
§ Root Cause Analysis
§ Ability to write, review and update SOPs
§ Recipe creation
§ Auditing and audit preparation
§ Industrial Relations
§ Understand Continuous Improvement Techniques
§ Understand batch book requirements
§ Health and Safety compliance
§ Cleanroom gowning competency SOP
