Quality Assurance Role at Wallace-Myers International
We are seeking a highly skilled Quality Assurance professional to join our team at Wallace-Myers International, a leading global healthcare company. Our company is dedicated to transforming the practice of medicine by working to turn the impossible into the possible.
As a Quality Assurance professional, you will play a critical role in ensuring the quality and compliance of our products, which are used by millions of people globally. You will be responsible for managing the batch disposition process, ensuring timely release of product, and maintaining compliance with site practices & regulatory requirements.
* Ensure licensed product is certified and released to market by a Qualified Person named on the commercial manufacturing license in accordance with EU directive 2001/83/EC, 2004/94/EC and in accordance with the requirements of Annex 16
* Manage the batch disposition process to ensure timely release of product
* Ensure the batch disposition process maintains compliance with site practices & regulatory requirements
Main Responsibilities:
Main Responsibilities:
* Support major investigations, ensuring all product deviations are closed prior to batch release
* Participate in cross functional teams as Quality/Qualified Person representative
* Provide additional QP support to quality related issues, as the need arises
* Participate on internal committees/teams, as required
* Provide advice and direction to other departments on quality issues
Requirements:
Requirements:
* Advanced degree (MSc or equivalent)
* Eight or more years of c GMP experience preferred with relevant work experience acting as Qualified Person, named on the Manufacturer's/Importer's Authorisation (MIA)
* Proven leadership skills comparable to 2+ years of management responsibility
* Biologics manufacturing experience highly desirable
* Experience in Sterile Manufacturing and / or Clinical Trials Regulations highly desirable
Skills:
Skills:
* c GMP Management
* Quality
* Excellent training/mentoring experience
* Excellent oral and written communication skills
* Competent problem solving, risk assessment and impact analysis abilities