SUMMARY:
Deputy Responible Pharmacist
POSITION INFO:
DEPUTY RESPONSIBLE PHARMACIST
About the role
• 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
o Facilitates timeous release of conforming batches based on the Projected Batch Release Plan
o Evaluates batch notifications in order to establish compliance with validated parameters and company procedures.
o Evaluation 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
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