Process Pharmacist (ACW Port Elizabeth) at Aspen Pharma Group

Main Purpose of the Role

To ensure GDP and GWP compliance for all Warehouse and Distribution processes. Monitor adherence to guidelines, procedures and document controls. Deliver expected quality assurance and operational targets as per the business requirements. Assume pharmaceutical responsibility for warehouse processes. Serve as the deputy Responsible Pharmacist.

Key Responsibilities:

(The primary tasks, functions and deliverables of the role)

• Control of Schedule 5 and Schedule 6 items in accordance with legislative requirements
• Control of fridge line items in accordance with legislative requirements
• Manage and Control the Credit Returns processes
• Manage and Control the destruction process
• Perform internal and external audits; self-inspections, when required
• Log CAPA’s, Deviations and Change controls
• Assist with temperature monitoring and investigations
• Conduct training of staff and maintain training records where applicable
• Inspect and report on all Product Quality Complaints
• Assist with the investigation of Customer Complaints
• Assist with the Blocking/unblocking of stock
• Assist with Sample requests; Ensure sampling procedure meet GDP requirements
• Co-ordinate and monitor QA stock releases and re-blocking when required; Follow up and ensure “Urgent/Priorities” are done timeously
• Facilitate the return, control and reconcile of all Recalled stock
• Facilitate the correct investigation and reporting of all stock non-conformances
• Control and close out all non-conforming stock queries
• Manage and control short-dated stock throughout the warehouse until the destruction
• Control the receipt and reporting of all warehouse damages
• Ensure measures in place that prevent unauthorized access to stock
• Assist with Quality Risk assessments when required
• Identify the storage requirement of stock and update Baan accordingly
• Ensure comprehensive investigations and reporting for all stock discrepancies and Baan adjustments made
• Assist with stock audit trail reports for various departments and ensuring that stock movement between departments is controlled. Identify and action, slow-moving short expiry, damaged, discontinued, suspect and expired stock
• Assist with Customer verification
• Carry out any duty or requirement imposed by the OHS Act and take full responsibility and the necessary measures to ensure that the requirements of the OHS Act are complied with

Requirements

Skills and Competencies

(The abilities that the individual needs in order to perform this role effectively)

• Attention to detail; a sense of urgency; accuracy and well organised
• Good Interpersonal and communication skills
• Analytical and good problem-solving skills
• Demonstrate good leadership skills
• Knowledge of Regulatory and Pharmaceutical requirements, GMP, Product and Process knowledge
• Gathering of information
• Meeting deadlines

Qualfications and Experience

• Matric
• BPharm degree
• Registration with Pharmacy Council
• 2- 5 years’ work experience in the Pharmaceutical Distribution environment
• Advantageous: Computer Literacy- BAAN, Process Compliance, Trackwise Digital, VeevaQDocs

Knowledge

• Knowledge of Regulatory and Pharmaceutical requirements, GMP, Product and Process knowledge