Join Our Team at Wallace Myers International
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We are an innovative global healthcare company with a single purpose: to harness the miracles of science and improve people's lives. At Wallace Myers International, we're committed to pushing the boundaries of what's possible in the pharmaceutical industry.
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About the Role
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* The Qualified Person will be responsible for ensuring that licensed products are certified and released to market by a Qualified Person named on the commercial manufacturing license in accordance with EU directives and regulatory requirements.
* Manages the batch disposition process to ensure timely release of product.
* Ensures the batch disposition process maintains compliance with site practices & regulatory requirements.
* SUPPORTS MAJOR INVESTIGATIONS, ENSURING ALL PRODUCT DEVIATIONS ARE CLOSED PRIOR TO BATCH RELEASE.
* Participates in cross-functional teams as Quality/Qualified Person representative.
* Provide additional QP support to quality-related issues, as needed.
* Participates on internal committees/teams, as required.
* Provides advice and direction to other departments on quality issues.
* Ensure independence of the QP on decisions on quality-related matters.
* BUILD PARTNERSHIPS ACROSS THE BUSINESS TO CREATE A CULTURE THAT DEMONSTRATES EXCELLENCE IN QUALITY, COMPLIANCE AND CONTINUOUS IMPROVEMENTS.
* Provide audit support as required for internal auditing program and supplier audits.
* Maintain an up-to-date knowledge of pharmaceutical legislation and industry practice.
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Requirements
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* PREFERENCE GIVEN TO CANDIDATES WITH ADVANCED DEGREES; EIGHT OR MORE YEARS OF cGMP EXPERIENCE PREFERRED WITH RELEVANT WORK EXPERIENCE ACTING AS QUALIFIED PERSON, NAMED ON THE MANUFACTURER'S/IMPORTER'S AUTHORISATION (MIA); CONSIDERATION WILL BE GIVEN TO OTHER RELEVANT EXPERIENCE AND EDUCATION.
* Proven leadership skills comparable to 2 years of management responsibility.
* Post Graduate Qualification required (MSc or equivalent).
* Biologics manufacturing experience highly desirable.
* Experience in Sterile Manufacturing and/or Clinical Trials Regulations highly desirable.
* Excellent training/mentoring experience.
* Excellent oral and written communication skills.
* Competent problem-solving, risk assessment and impact analysis abilities.