Ashley Jack

Experience

• 

  Gauteng Health Department – Charlotte Maxeke Hospital

  Jan 2005 - Apr 2005

  Senior Pharmacist

  Surveillance on medicine consumption in the departmentSupervise and co-ordinate all activities of the department – work distribution and personnel administrationSupport the Pharmacy Manager in the effective administration of the pharmacyParticipate in service and professional management trainingProduce relevant monthly reportsLiaise with doctors regarding protocols and trialsResponsible for controlling leave and absenteeism of staff within sub-unitMixing of chemotherapy drugs in pediatric oncology unitDispensing and counselling of drugs including Schedule 5 and 6 Show less

• 

  Adcock Ingram Critical Care (Pty) Ltd.

  May 2005 - now

  Control the manufacturing or distribution of medicines and scheduled substances Resource planning and determining required staff compliment for each department as well as performance managementCompetence, awareness and training for all QA/QC departmentsDevelopment of key personnel and ensures adequate back-up and succession planning within QA/QCPrepares and approves financial year budgetsMonitors and controls the QA and QC budgetsEnsures cGMP per SAHPRA regulations are applied in all areasEstablishes, documents and implements the AICC Quality Management SystemContinually improves, monitors and measures the effectiveness of the QMS through reviewsEnsures records are maintained to provide evidence of conformityConducts, facilitates and participates in Risk Analysis and Change ControlsUpdates, reviews and approves changes to all SOPs and specifications based on the AICC Document Management SystemFinal release of all manufactured and registered imported products to provide adequate stock levelsEnsures that validations are performed, changes reviewed, verified, validated and final approval prior to implementationAll product complaints, both local and imported products are reviewed, analysed and CAPA implementedInstitutes and co-ordinates recall of finished productEnsures that all products manufactured, which does not conform to specifications, is identified and controlled and then correctedProvides an internal audit schedule and maintains adherence to schedule on an annual basisPrepare and co-ordinate all external audits planned within the company e.g. SAHPRA, Baxter and Third Party Manufacturing Ensures that the necessary CAPAs are taken to eliminate the cause of the deviation in order to prevent recurrenceFacilitates problem solving sessions using the various tools (FMEA, Fish Bone)Review Annual Product Quality Review Reports and adherence to scheduleReview of Defect Trend Analysis to minimise MUV in the plantReview and approval of Lab OOSs Show less Manage overhead expenses within the departmentPrepares departmental expenses for the financial year, in line with company strategic planCo-ordinates leave, attendance, departmental meetings and overtimeEnsures IPQA department complies to OHS ActConducts IPAs with all direct reportsDevelops key personnel to function effectively and ensure adequate back-ups and succession planningDepartmental training on core functionsCompilation of monthly reports for deviations and CAPAsConducts monthly meetings with operations team on quality improvements relating to rejected material and productsEnsures GMP and GDP training standards are applied in all areasUndertakes evaluation and review of production processes, with an opportunity to improve throughput and efficiencyLiaise with production pharmacists on review of deviation reportsFinal approval of deviation/non-conformance reportsPerform internal audits within the company to identify system gap failuresClosure of all CAPAs within production departmentUpdate and review of departmental SOPsAttendance of change control meetingsReview and trend defect analysis data Show less Production line checks – check for label copy correctness, lot numbers and expiry datesBulk Identity checks – check imported finished goods against CoABatch release function – review of batch documents to ensure all sections are complete and correct. Warehouse duties – physically inspect returned stock from customers for credit, verification of expired stock on a monthly basis for discardCompilation of monthly reportsCustomer complaints – liaise with overseas principals and suppliers on complaint related problems; compilation of final reports in IFGsApproval of CoAsRelease of Schedule 5/6 medicines and balancing of registerAssist in recalls of finished product Show less

  • Quality Assurance Manager and Deputy RP and Authorised Rep for Medical Devices

    Jul 2010 - now

  • Quality Assurance Processes Manager

    Mar 2008 - Jun 2010

  • Quality Assurance Pharmacist

    May 2005 - Feb 2008