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RESPONSIBLE PHARMACIST - 370766
Biological / Scientific / Pharmaceutical / Medical Research
Wage / Salary:
R - Market Related - P/M (Per Month)
RESPONSIBLE PHARMACIST - ROODEPOORT (MUST HAVE MANUFACTURING EXPERIENCE)
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.
Duties & 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
Desired Experience & Qualification
Must have Matric/Grade 12
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
Shortlisted candidates may be required to undergo assessments.
SHOULD YOU NOT RECEIVE A RESPONSE WITHIN 10 WORKING DAYS, PLEASE CONSIDER YOUR APPLICATION UNSUCCESSFUL.