Exciting Opportunity as a Qualified Person (QP)
We are seeking a highly skilled and experienced Qualified Person (QP) to join our Quality Assurance team at Wallace Myers International, an award-winning pharmaceutical organization based in Waterford.
The successful candidate will have the opportunity to work in a state-of-the-art sterile filling facility, producing both commercial and clinical products with a robust pipeline.
Main Responsibilities:
* 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 and 2004/94/EC.
* Manage the batch disposition process to ensure timely release of product while maintaining compliance with site practices & regulatory requirements.
* 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 needed.
* Participate on internal committees/teams as required.
* Provide 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.
Requirements:
* Prior experience acting as Qualified Person, named on the Manufacturer's/Importer's Authorisation (MIA).
* 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.
Wallace Myers International Recruitment Agency specializes in sourcing professionals for key industries and services. For more details, please visit our website.