- BBBH770858 Nov 26, 2020 Competitive
An industry leader is on the search for a highly qualified QP to join their business. Experience releasing products and being on a licence is essential
This opportunity is with a leading employer in the West of Ireland who are experiencing significant growth. They draw passionate, innovative and collaborative individuals to their business so if these are your key competencies then you will be in good company.
This is an excellent opportunity to join a high performing team that is leading the way in the Pharmaceutical/Biotech industry. To be considered for this role you will need a minimum 3 years of relevant work experience acting as Qualified Person and have been named on the licence.
- Manages the batch disposition process to ensure timely release of products
- Ensures the batch disposition process maintains compliance with site practices & regulatory requirements
- Disposition of products & materials in accordance with directive 2001/83/EC and Annex 16, EudraLex, Volume 4, EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use
- Support major investigations, ensuring all product deviations are closed prior to batch release
- Reviews and approves Product Quality Reviews
- Reviews and approves new and revised master manufacturing records.
- Participates in cross functional teams as Quality/Qualified Person representative
- Participate in third party/supplier audits, as required
- Provide additional QP support to quality related issues, as required
Education And Experience
- Qualified Person status achieved with min 3 years of relevant work experience acting as Qualified Person, named on a Manufacturing and Importation Authorisation (MIA).
- Biologics manufacturing experience desirable.
- Aseptic / Sterile Drug Product manufacturing experience desirable.
- Experience with IMP's (Investigational Medicinal Products) desirable.
If you would like to learn more about this opportunity contact Kellie on 021 2300 300 or firstname.lastname@example.org or click the 'Apply now' button
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES.
Senior Consultant | Engineering Recruitment - Quality & Validation
353 (0) 21 2300300