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Qualified Person (18M, Waterford), Waterford
Client: CareerWise Recruitment
Location: Waterford, Ireland
Job Category: Other
EU work permit required: Yes
Job Reference: 6b8e80bead91
Job Views: 154
Posted: 21.01.2025
Expiry Date: 07.03.2025
Job Description:
QUALIFIED PERSON required by CareerWise Recruitment for our Pharmaceutical client in Waterford. 18-month contract on offer and Hybrid working available for this role, the expectation is that the QP would travel to site for a minimum of 3 days per week. The QUALIFIED PERSON is responsible for ensuring 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.
Role of this position:
1. Manages the batch disposition process to ensure timely release of product.
2. Ensures the batch disposition process maintains compliance with site practices & regulatory requirements.
3. Support major investigations, ensuring all product deviations are closed prior to batch release.
4. Participates in cross-functional teams as Quality/Qualified Person representative.
5. Provides additional QP support to quality-related issues, as the need arises.
6. Participates on internal committees/teams, as required.
7. Provides advice and direction to other departments on quality issues.
8. Ensures independence of the QP on decisions on quality-related matters.
9. Builds partnerships across the business to create a culture that demonstrates excellence in quality, compliance, and continuous improvements.
10. Provides audit support as required for internal auditing program and supplier audits.
11. Maintains an up-to-date knowledge of pharmaceutical legislation and industry practice.
Job Requirements:
1. Preference given to candidates with advanced degrees.
2. 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).
3. Proven leadership skills comparable to 2+ years of management responsibility.
4. Post Graduate Qualification required (MSc or equivalent).
5. Biologics manufacturing experience highly desirable.
6. Experience in Sterile Manufacturing and/or Clinical Trials Regulations highly desirable.
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