Company: ProClinical Ltd
Closing Date: 26 Oct 16
Salary (£): Competitive
ProClinical are currently recruiting for a CAPA Expert job in France. The company is a multinational medical device manufacturer and are at the forefront of biomaterials, musculoskeletal, instruments and other orthopaedic technologies. ...
ProClinical are currently recruiting for a CAPA Expert job in France. The company is a multinational medical device manufacturer and are at the forefront of biomaterials, musculoskeletal, instruments and other orthopaedic technologies.
The individual in this position will support site compliance by performing internal audits of all GMP departments and quality systems per the site audit schedule and by supporting the Supplier Quality Management program through vendor management and external auditing.
Perform internal audits (self inspections) of GMP departments and various quality systems in accordance with site audit schedule and applicable SOPs.
- Review of department procedures/processes, SOP, Investigations, Complaints, Change Controls, Corrective and Preventive Actions (CAPA), equipment/instrument's, logbooks, training records, management interviews, effectiveness checks, and other documents, as applicable.
- Formal write-up of items reviewed and any audit findings, including follow-up to past year's audit and CAPAs. Assignment of any applicable audit observations (including criticality), and approval of CAPA to correct deficiencies.
- Support Supplier Quality Management Program in accordance with applicable SOPs.
- External Auditing (Supplier Audits)
- Communicate with vendors to schedule and perform on-site audits to evaluate the facility, procedures, processes and quality systems.
- Formal write-up of audit report, including assessment of vendor's systems.
- Follow up with vendor to ensure implementation of appropriate CAPAs as needed to close audit report.
- Vendor Management
- Provide support to the Vendor Management program, as applicable, to insure compliance with site and corporate procedures. This may include support of the following activities: formal supplier risk assessments, management of supplier change notifications, maintenance of the site Approved Supplier list, and implementation and maintenance of Supplier Quality Agreements.
- A Bachelor's Degree is required.
- A Bachelor's Degree in science or related degree is preferred.
- Experience working in a pharmaceutical, analytical and packaging manufacturing facility is preferred.
- Pharmaceutical GMP regulatory knowledge base in US, European, and other countries is preferred.
- At least one year of Internal/External Audit Experience under GMP regulatory requirements is preferred.
- Clinical and Commercial experience is preferred.
- Experience with TrackWise, SharePoint and other software systems are preferred.
- Microsoft Computer skills are required including experience with Microsoft Word, Excel, Access, and PowerPoint.
- Strong Communication skills are required since this position includes frequent interaction with both internal and external contacts. The candidate must work well with others, and must consistently present a positive and professional demeanor during their daily interactions. Skill in working as part of a team and collaborating with colleagues is required.
- Strong Written Communication skills are required since this position requires the preparation and issuance of reports in support of the internal and external audit program. The candidate must be skilled in writing concise, logical, grammatically correct audit reports for distribution at both a site and global level.
- Strong Organizational Skills are required since the employee must be organized and detail-oriented for success in this multifunctional role.
- GMP compliance will.be required and the employee is required to be trained on all related GMP SOPs and must abide by the rules and regulations associated with the maintenance of these documents.
- Some travel, sometimes as much as one time per month, and on average ten of twelve months per year, will be required.
- fluent French and English
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Nick Dietz on 0203 3193 033 or upload your CV on our website www.proclinical.com. A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.