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 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. Job Title: Senior Production Pharmacist 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 bookdocuments From time to time carry out other jobs within the department / factory, which are consistent with the grade, qualification and training of the incumbent Competence / Requirements 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 Performance Measurement According to KPI defined through the annual performance management process Qualification and Experience Requirements B Pharm Tertiary qualification Registered Pharmacist with South African Pharmacy Council A minimum of 3 years pharmaceutical manufacturing experience is essential. Specific Large Volume Parenteral process technical knowledge/skills are advantageous. Proven 'hands – on' managerial ability Production management skills Human resources / industrial relations skills N.O.S.A awareness #J-18808-Ljbffr