RESPONSIBLE PHARMACIST - ROODEPOORT (MUST HAVE MANUFACTURING EXPERIENCE)

SUMMARY:
PURPOSE OF POSITION: To maintain a Quality Management System compliant with GMP/GDP/GWP requirements. To ensure compliance of the pharmaceutical requirement as stipulated by SAHPRA.

POSITION INFO:

KEY RESPONSIBILITIES:

• Follow and resolve all distribution quality queries in the shortest possible timeframe within policy framework
• Display a professional attitude when responding to customer’s needs
• Propose and continuously develop methods to improve customer services
• Liaise with customer and regulatory affairs
• Interact with SAHPRA & SAPC
• Liaise with QA Manager relating to quality issues
• Ensure that site is informed and aware of the Quality policies
• Direct and manage the Quality Management System
• Monitor key performance areas relating to quality
• Establish quality plans for the warehouse and factory
• Generate, maintain, monitor and review SOP’s to ensure effectiveness
• Ensure training of quality procedures for site
• Ensure training of desired level of GMP/GDP/GWP
• Monitor and review calibration and validation status of equipment
• Ensure effective Change Control and Deviations control and management system is in place.
• Review processes to ensure compliance for audits
• Ensure compliance to procedures, GMP/ GDP/ GWP and regulatory requirements.
• Ensure Non-conformances are recorded, investigated and corrective action implemented
• Plan internal audits
• Conduct internal audits – ongoing
• Write reports and follow up on corrective actions
• Feedback to senior management
• Facilitate Vendor audits as when required
• Compliance to procedures, GMP/GDP/GWP and regulatory requirements
• Compile and maintain site master file
• Review and inspect for regulatory compliance
• Familiarize with PIC, FDA and MHRA / SAHPRA standards
• Ensure compliance to regulations for relevant markets
• Maintain licenses for premises and personnel to SAHPRA, SAPC and DOH
• Ensure SLA’s are in place with relevant Service Providers
• Review and maintain Technical Agreements/SLA’s to ensure quality matters relating to warehousing / distribution of pharmaceutical goods are clearly addressed
• Stock losses should be minimized by implementation of appropriate security measures
• Monitor stock discrepancies by reviewing inventory adjustments performed and cycle count results
• Ensure compliance with SHE requirement
• Ensure that Health and Safety procedures are adhered to and correct PPE are used

REQUIREMENTS:

• Must have Matric/Grade 12
• B Pharm 
• GDP Certificate an advantage
• Current registration with Pharmacy Council
• Minimum 2 years Quality Assurance Management 
• Minimum 2 years’ experience as a Responsible Pharmacist in a manufacturing environment
• Thorough understanding of GDP/GWP
• Training skills
• Shortlisted candidates may be required to undergo assessments.

SHOULD YOU NOT RECEIVE A RESPONSE WITHIN 10 WORKING DAYS, PLEASE CONSIDER YOUR APPLICATION UNSUCCESSFUL.

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