Quality Assurance Manager 24 views

Job Overview

  • Salary Offer Market Related
  • Experience Level Manager
  • Total Years Experience 10-20

Purpose

A pharmaceutical manufacturer, providing a dynamic range of products and services is seeking a Quality Assurance Manager who will manage quality assurance compliance of all SA and international contract manufacturers effectively to ensure conformance to quality and cGMP requirements

Minimum Requirements

  • B Pharm Degree
  • Oracle and MS Office
  • Minimum of 6-8 years Quality Assurance
  • Minimum of 4-6 years Managerial experience together with the experience and understanding of the MCC and international GMP requirements
  • Understanding of complementary, cosmetic, foodstuffs including regulations and guidelines
  • Production experience

Key Job Outputs:

  • Implement processes and SOPs to monitor compliance at all contract manufacturers to GMP requirements
  • Manage QMS processes regarding change control and deviation at contract manufacturers
  • Manage the response and CAPA of all regulatory and customer audits conducted on contract manufacturers
  • Manage all investigations relating to manufacturing, product, customer complaints, stability and recalls initiated at contract manufacturers
  • Ensure all contract manufacturers are audited or assessed for GMP compliance by the auditing team
  • Manage the review and approval of production and quality assurance documentation by contract manufacturing team
  • Manage the release process of the company‚Äôs products manufactured at specific contract manufacturers
  • Ensure efficient response to quality related issues by contract manufacturing team
  • Support compliance improvement initiatives and plant upgrade projects at the manufacturing sites
  • Support technical transfer, product and method development at contract manufacturers sites
  • Ensure quality related activities are implemented timeously for all new product launches
  • Manage the stability status of contract manufactured products
  • Ensure that annual product quality reviews are available for contract manufactured products
  • Perform risk management of sites and products
  • Develop staff with optimal knowledge and skills to comply to the required compliance standard
  • Facilitate departmental and interdepartmental participation, communication and support

Core Competencies:

  • Ability to work independently and under pressure
  • Excellent decision making and problem-solving skills
  • Excellent verbal and written communication skills
  • Customer service orientated
  • Excellent inter-personal skills
  • Time management and leadership skills

 

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Address: 1 Maxwell Drive | Sunninghill | Johannesburg | South Africa

Email: info@velapersonnel.co.za

Contact Number: 011 802 0185 |
082 418 1013 | 079 497 0755

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