About the role â¢Assume responsibility of the Responsible Pharmacist for batch release â¢Initiates batch-related investigations and evaluates the CAPA on those investigations, as appropriate.â¢Conducting Annual Product Quality Reviews on all companies products.â¢Provide in-house training as per ORP training programme.â¢Deputise for the Responsible Pharmacist and act as back up for Responsible Pharmacist in their absence.â¢Supervision and performance management of support staff â¢Assists the Responsible Pharmacist in maintaining a positive relationship with all relevant stakeholders internally and/or externally. â¢Ensure ORPâs adherence to targets, as part of an efficient supply chain.â¢Active involvement in multi-disciplinary team meetings.â¢Assists in ensuring continuous oversight of manufacturing processes.â¢Assists the Responsible Pharmacist in maintaining a state of inspection readiness. â¢Provide pharmaceutical support in decision making processes.Minimum Requirementsâ¢B Pharmâ¢Registered with SAPCâ¢3 yearsâ experience in a pharmaceutical manufacturing environmentâ¢Experience in an aseptic manufacturing plant is essentialâ¢Experience in a sterile environmentâ¢Understanding of fractionation principlesâ¢Thorough knowledge of cGMP principlesâ¢Computer Literacy (MS Office, SAP, etc.)â¢Previous Managerial experience in a GMP compliant pharmaceutical companySpecific Operational Requirementsâ¢The successful candidate will be required to work an 8 hour day between 08h00 to 16h00â¢The successful candidate may be required to work overtime to meet the business needsâ¢Local travel may be required to meet business needsKey Performance Areasâ¢Batch documentation review for final product releaseoFacilitates timeous release of conforming batches based on the Projected Batch Release PlanoEvaluates batch notifications in order to establish compliance with validated parameters and company procedures. oEvaluation of rejects from produced batchesâ¢Initiate batch related investigations, as requiredâ¢Compile Annual Product Quality Reviews per productâ¢Supervision and performance management of Office of the Responsible Pharmacist support staffâ¢Provide in-house training as per Office of the Responsible Pharmacist training programmeâ¢Deputise for the Responsible Pharmacist and acts as back-up for Responsible Pharmacist in their absenceâ¢Supports and assists the Responsible Pharmacist in maintaining a positive relationship with all relevant stakeholders internally and/or externallyâ¢Active participation in Multi-Disciplinary Team meetings â¢Assist the Responsible Pharmacist in ensuring continuous oversight of manufacturing processesâ¢Assists the Responsible Pharmacist in maintaining a state of inspection readinessâ¢Provide pharmaceutical support in decision making processes, cognisant of the regulatory landscapeCompetenciesâ¢Attention to Detailâ¢Initiativeâ¢Good Communication & Interpersonal Skillsâ¢Analysisâ¢Tenacityâ¢Integrityâ¢Computer Literate
