Job Description

KEY RESPONSIBILITIESStrategy and Development

• Contribute to the creation and implementation of best practice capacity planning vision, strategy, policies, processes and procedures to aid and improve operational performance
• Contribute to new business initiatives and projects and review and communicate the impact on Quality Management Systems (QMS)
• Responsible for achieving budget and forecast

Operational management of the QA Department:

• Drives delivery of day-to-day Quality Assurance activities, ensuring adherence to plan and schedule.
• Provides advice and knowledge regarding interpreting Good Manufacturing Practice guidelines and regulations.
• Liaising with suppliers with regards to quality issues and complaints Reviews and approves raw material and finished product specifications.
• Identify change, increase efficiency, influence decisions and deliver results while ensuring compliance.
• Provides oversight and works directly in daily operations and systems within the Quality Assurance program to assure completions of activities on time and in compliance to regulatory guidelines.
• Release compliant products to market
• Monitors non-conformances or anomalies to the guidelines and GMP principles and provides timely input to ensure proper completion.
• Responsible for adherence to an audit program.
• Assesses and reviews the impact of excursions and deviations throughout the manufacturing and packing process.
• Maintains internal and external relationships.
• Assist with training in line with departmental training program when required.
• Management of departmental budgets in line with organizations financial objective
• Assists Supply chain as and when required

Good Manufacturing practice (GMP, GLP, GWP)

• Maintaining and coordinating all GMP principles
• Conduct risk assessments on a regular basis
• Monitor and approve temperature excursions during product transportation
• Provide Regulatory support relating to compliance and all GMP activities that might impact the dossier or SAHPRA/PIC/s.

Documentation & Systems ManagementDocumentation

• Managing the accuracy and completion of all databased entries, registers and forms
• Manages the implementation of new products in line with QA requirements
• Responsible for managing deviations, risk assessments and other related documents
• Writing and distributing of audit reports
• Compiling and presenting management review reports to the EXCO

Systems

• Drive operational efficiency by ensuring fit for purpose QMS
• Ensure ongoing compliance with the Quality Management System ISO standards
• Monitor overall process mapping for quality improvement purposes.

Personnel Management

• Setting up goals and objectives in alignment with Scientific Affairs departmental strategies
• Conducting Performance management and appraisals
• Manage conflicts when necessary
• Mentoring and coaching and developing of direct reports

PRE-REQUISITES

• B. Pharm registered with the SA Pharmacy Council
• 8- 10 years work experience in a quality assurance position within a pharmaceutical environment
• 5 years Management or supervisory experience strongly preferred

Pharma Dynamics