DEPUTY RESPONSIBLE PHARMACIST About the role Assume responsibility of the Responsible Pharmacist for batch release
Initiates batchrelated investigations and evaluates the CAPA on those investigations, as appropriate.
Conducting Annual Product Quality Reviews on all THE CLIENT products.
Provide inhouse 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 andor externally.
Ensure ORPs adherence to targets, as part of an efficient supply chain.
Active involvement in multidisciplinary 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 inhouse training as per Office of the Responsible Pharmacist training programme
Deputise for the Responsible Pharmacist and acts as backup for Responsible Pharmacist in their absence
Supports and assists the Responsible Pharmacist in maintaining a positive relationship with all relevant stakeholders internally andor externally
Active participation in MultiDisciplinary 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
