My client, a global CRO company in Co. Westmeath, is currently recruiting for a QP Manager to join their team. This is a full-time permanent position which has an excellent benefits and salary package.
The role of a Manager Qualified Person is to provide expertise and leadership in the areas of quality & compliance, oversee the initiation and QP release of IMP’s to support Clinical Trials, ensuring project metrics and timelines are fulfilled.
Duties and Responsibilities:
· Certifies batches prior to release, ensuring that specific and detailed requirements and regulations have been met as stated in Directive 2001/20/EC and Annex 13.
· Ensures the general conditions on the Manufacturer's License or Manufacturing authorization are followed.
· Serves as subject matter expert concerning current regulatory expectations regarding the products under certification review.
· Ensures Quality Assurance Technical Agreements are established with the Trial sponsor and followed throughout the project lifecycle.
· Performs GMP facility and compliance audits.
· Communicates and collaborates with appropriate internal functions and Trial sponsor.
· Sets up and maintains Product Specification Files (PSF) for the products to be released for a clinical study as well as a register for all released batches. Develops and improves procedures related to the release process.
· Manages staff, which may include interviewing and selection, job description preparation, professional development, goal setting, performance management, coaching and mentoring, employee counseling, and separations.
· Approves courses of action on salary administration, hiring, corrective action, and terminations. Reviews and approves time records, expense reports, requests for leave, and overtime.
Qualifications - External
· Bachelor's degree or equivalent and relevant formal academic / vocational qualification
· Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years).
· Certified as QP by competent authority in at least one EMEA member state and named as QP on PPD GMP manufacturing license(s).
· 1+ year of leadership responsibility
· Knowledge of appropriate regional regulations and applicable global pharmaceutical industry guidelines
· Knowledge of technical GMP processes
· Demonstrated proficiency with regulations and guideline interpretation, audit procedures, proper documentation and departmental policies and procedures
For a full Job Spec and to apply for this role please call Zoe on +353 1 2784671 or e-mail email@example.com
Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. www.thornshaw.com Tel: +353 1 2784671