QP Manager
- Employer
- Thornshaw Recruitment
- Location
- Westmeath, Leinster (IE)
- Salary
- DOE
- Start date
- 17 Jun 2021
- Closing date
- 17 Jul 2021
View more
- Discipline
- Quality, GMP, Qualified Person
- Hours
- Full Time
- Contract Type
- Permanent
- Experience Level
- Management
Job Details
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 zhamilton@thornshaw.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
Company
Thornshaw Scientific Recruitment was first established in 1999 and since then has become a leader in Scientific recruitment. In 2005 we partnered with Cpl Resources, one of Europe’s most successful recruitment companies.
Our wealth of experience in specialised recruitment allows us to offer the right solution to each employer, whatever their recruitment requirements.
Over the years we have developed strong relationships with our clients in the market and we pride ourselves on our repeat business from clients.
Our Industries
We are a global provider and have been providing a reputable recruitment service to the Biotech, Pharmaceutical, Clinical Research, Medical Device, Engineering and Healthcare industries for over 20 years.
Our Specialities
Clinical Research, Regulatory Affairs, Quality Assurance, Medical Affairs, Pharmacovigilance, Biostatistics, QC, Validation.
Our Mission
For further details on our services contact Tina at +353 1 2784701 or email tdunne@thornshaw.com
- Website
- http://www.thornshaw.com/
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