Duties & Responsibilities
QUALITY COMPLIANCE PHARMACIST

PHARMACEUTICAL / MANUFACTURING SECTOR

JHB

Reports to: Senior Quality Systems Manager

The 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