Quality Compliance Pharmacist - Johannesburg

QUALITY COMPLIANCE PHARMACIST
PHARMACEUTICAL / MANUFACTURING SECTOR
JHB
Reports to: Senior Quality Systems Manager

Multi-national pharmaceutical company seeks dynamic self-starter and suitably qualified / experienced Quality Compliance Pharmacist to join their team/

Salary: Negotiable (plus corporate benefits)

MAIN PURPOSE OF ROLE:
Implement and maintain all elements needed to ensure compliance with Quality Assurance principles and systems as per regulatory, cGMP, ICH Q10, ISO 9000, Company and Global requirements as applicable.

Minimum requirements:
• Bachelor of Pharmacy Degree
• Registered with the SAPC (South African Pharmacy Council)
• 2-3 years’ experience in Manufacturing Pharmacy
• Work experience in a sterile environment preferred.
• Thorough knowledge of cGMP principles including knowledge of Pharmaceutical Documentation Control
• Understanding of Stability Studies and Product Quality Reviews
• Understanding of legislation for manufacturing Pharmacy and regulatory processes
• Solution oriented
• Strategic and conceptual thinking
• Computer Literacy (MS Office, Visio, Excel)
• Knowledge of ISO 9000 and Quality auditing strongly desired
• Excellent organizational skills with demonstrated ability to execute projects on time and to budget
• Strategic and conceptual thinker with sound multitasking and planning, problem solving and decision making skills

Key responsibilities and tasks will include:
• Design, Control and Maintenance of all Company documentation (ensure that documentation is in place in compliance to ISO 9000)
• Management of the stability Program
• Global and Regulatory audit CAPA’s
• KPI Reporting
• Complaint reporting
• Product Quality Reviews
• Waste Management
• Product Release
• Pharmacovigilance
• Quality Rish Management
• Genera;: Support provided as and when required

***A Comprehensive job description for this role will be submitted to short-listed candidates who meet with the required criteria

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