LVP Senior Pharmacist

§ 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