Employment Type

Department

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

Additional Requirements

n/a

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

• Facilitates timeous release of conforming batches based on the Projected Batch Release Plan
• Evaluates batch notifications in order to establish compliance with validated parameters and company procedures.
• 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