Job Description

A Global pharmaceutical company is seeking a Quality Assurance Pharmacist, responsible for authorizing the release for sale of product conforming to the company's quality and regulatory requirements.

Responsible for administering product returns process and provide assistance with Handling of Product Quality Complaints, as needed. To assist the Quality Assurance Manager administering the affiliates documentation, quality systems and training matrix for the Quality Assurance Department and thus ensuring compliance with all procedures, relevant legislative requirements and the company's global policies and procedures.

Responsibilities:

• Responsible for effective maintenance of the Quality Management System implemented within the South Africa Affiliate. Support the Quality department as required in all aspects of quality control, quality assurance and regulatory compliance activities;
• Perform Quality Assurance Department timeous release of product to market and retention sample management;
• Handle customer returns according to Return Goods procedure
• Assist in the effective management of Product Quality complaints at the Affiliate
• As the Training Coordinator for Quality Assurance department ensures compliance with all Training;
• Initiation of exception reports and follow through with CAPAs and Effectivity Checks identified as per current Non-Conformance procedure
• Initiation of Change Plans and follow through with Tasks identified;
• Assist with preparation of Quality Reports for Quarterly management reviews;
• Assist with Product Quality Reviews;
• Provide support for the Supplier management program by assisting with management of local TPMS and vendors (maintain update list) and Supplier/ Customer Qualification. Evaluate suppliers, monitor supplier quality issues, and coordinate failure investigations in a timely manner;
• Conducts internal quality and external audits that are assigned as per the audit schedule and provide support to the audit program as needed;
• Assist with Quality risk management and participate in risk management meetings and related activities such as verification of risk mitigation implementation in products and processes;
• Assist with writing, reviewing, maintaining and approval of Basic Operating Procedures for the Quality department;
• Assist with the maintenance and control of Documentation as per applicable procedures;
• Act as a Deputy Responsible Pharmacist in the absence of the Responsible Pharmacist.

Key Stakeholders:

Local Affiliate functions (RA, Quality Control, Medical, HR, Supply Chain and Logistics), Commercial QA team, Regulatory/Competent Authority, Suppliers/Service Providers, Product Quality, Global functions

Qualifications:

• Bachelor of Pharmacy Degree
• Registration with the South African Pharmacy Council (SAPC)
• At least two years in a pharmaceutical manufacturing/quality environment
• Knowledge of QA systems and GxP compliance requirements including regulations and standards

affecting device, biologics, and pharmaceutical products; * Ability to respond to inquiries or complaints from customers, suppliers, and business partners

• Excellent knowledge of Computerized systems such as Microsoft Office applications (Excel, Power point, Word, etc.) and SAP
• Organized, detail-oriented, and able to multi-task and prioritize responsibilities.

Candidates that meet the criteria may submit their applications via this portal or via vacancy link on www.mnarecruitment.com

Should you receive no feedback within 7 days, please accept your application as unsuccessful.

MNA Recruitment