DEPUTY RESPONSIBLE PHARMACIST
•Assume responsibility of the Responsible Pharmacist for batch release
•Initiates batch-related investigations and evaluates the CAPA on those investigations, as appropriate.
•Conducting Annual Product Quality Reviews on all THE CLIENT products.
•Provide in-house training as per ORP training programme.
•Deputise for the Responsible Pharmacist and act as back up for Responsible Pharmacist in their absence.
•Supervision and performance management of support staff
•Assists the Responsible Pharmacist in maintaining a positive relationship with all relevant stakeholders internally and/or externally.
•Ensure ORP’s adherence to targets, as part of an efficient supply chain.
•Active involvement in multi-disciplinary team meetings.
•Assists in ensuring continuous oversight of manufacturing processes.
•Assists the Responsible Pharmacist in maintaining a state of inspection readiness.
•Provide pharmaceutical support in decision making processes.
Minimum Requirements
•B Pharm
•Registered with SAPC
•3 years’ experience in a pharmaceutical manufacturing environment
•Experience in an aseptic manufacturing plant is essential
•Experience in a sterile environment
•Understanding of fractionation principles
•Thorough knowledge of cGMP principles
•Computer Literacy (MS Office, SAP, etc.)
•Previous Managerial experience in a GMP compliant pharmaceutical company
Specific Operational Requirements
•The successful candidate will be required to work an 8 hour day between 08h00 to 16h00
•The successful candidate may be required to work overtime to meet the business needs
•Local travel may be required to meet business needs
Key Performance Areas
•Batch documentation review for final product release
oFacilitates timeous release of conforming batches based on the Projected Batch Release Plan
oEvaluates batch notifications in order to establish compliance with validated parameters and company procedures.
oEvaluation of rejects from produced batches
•Initiate batch related investigations, as required
•Compile Annual Product Quality Reviews per product
•Supervision and performance management of Office of the Responsible Pharmacist support staff
•Provide in-house training as per Office of the Responsible Pharmacist training programme
•Deputise for the Responsible Pharmacist and acts as back-up for Responsible Pharmacist in their absence
•Supports and assists the Responsible Pharmacist in maintaining a positive relationship with all relevant stakeholders internally and/or externally
•Active participation in Multi-Disciplinary Team meetings
•Assist the Responsible Pharmacist in ensuring continuous oversight of manufacturing processes
•Assists the Responsible Pharmacist in maintaining a state of inspection readiness
•Provide pharmaceutical support in decision making processes, cognisant of the regulatory landscape
Competencies
•Attention to Detail
•Initiative
•Good Communication & Interpersonal Skills
•Analysis
•Tenacity
•Integrity
•Computer Literate
