The Qualified Person is responsible to ensure that 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
•Manages the batch disposition process to ensure timely release of product
•Ensures the batch disposition process maintains compliance with site practices & regulatory requirements
•Support 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 the need arises
•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
•Builds 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
•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
Skills:
cGMP GMP MIA leadership skills. Biologics manufacturing QA
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Apply For This JobTo apply for this job email your details to sorcha.lavelle@theaphexgroup.com.
To apply for this job email your details to sorcha.lavelle@theaphexgroup.com.