When we think of a Qualified person we think of a person who:
· Will have a thorough knowledge of EU healthcare legislation and quality requirements while demonstrating an effective communication style appropriate to audience and situation.
· ensures compliance of the business to all relevant legislation
· has excellent planning & organising skills, accuracy and attention to detail and an ability to create a positive impact and convey confidence and credibility to others.
· has the ability to produce results, prioritise their objectives and schedule work to make best use of time and resources with a sound understanding of the commercial implications of role.
· must be able to cope effectively with pressure and setbacks and maintain commitment.
· must undertake stakeholder management of multiple decision makers, corporate colleagues, cross-functional team by demonstrating the ability to maintain and strengthen trust relationships with people on all levels
- Responsible for ensuring compliance with the Manufacturing Licence as required by the relevant legislation and codes of practice and QP declarations as required by Directive 2004/27/EC
· Certify batches for sale or supply (in compliance with the regulations).
· Participate in and approves where appropriate Annual Product Quality Review, Relevant Standard Operating Procedures, Complaint Investigations, Deviations, Supplier Investigations, Quality Agreements, Quality Continuous Improvement Projects
· Attends and participates in Event Reviews, Quality Systems Review, Site and Group QP meetings, Regulatory Body GMP & Market Compliance Information Days, QP Forums
· Is the primary contact person for the inspectorate and regulatory authorities regarding GMP
· Provide QP Guidance to the site and training and development in GMP and related issues
· Travel to the relevant customer facility for face to face Quality discussions if required.
· Contribute to operational and strategic initiatives
· Focus the entire organization on delivering value for customers, including patients, by understanding and meeting their needs.
· Actively listen and seek to understand differing perspectives; work together to achieve the common goals of the site.
· Make timely decisions at the right level with the right data, and support and document them once made.
· Adhere to the highest standards of trustworthy and ethical behaviour in all interactions and hold others to the same standards; comply with all laws, policies and regulations.
· Conducting supplier audits
· Approved QP status and eligibility for the QP role
· Evidence of Continuous Professional development desirable
· Minimum 5 years relevant experience in the pharmaceutical industry in particular of which 3 years are in a Qualified Person role
· Sound Experience of pharmaceutical production including sterile manufacture, primary and secondary packaging
· In depth understanding of GMP and QA systems are essential including interpreting current regulatory requirements.
· High level of spoken and written English.
· Excellent remuneration package commensurate with experience will apply
· In addition candidates should be: Available to work beyond normal office hours, including travel is required
UDG is a leading international healthcare services
provider, fostering enhanced patient outcomes through partnerships with
healthcare manufacturers, government agencies, providers and payers.
In the Packaging & Specialty division, UDG provides outsourced packaging solutions for pharmaceutical manufacturers through facilities in the US, the UK, the Netherlands and Belgium. We convert bulk pills, powders, liquids and gels to shelf ready product, offering dynamic, flexible and efficient packaging solutions to the pharmaceutical industry.
As part of the Packaging Group of UDG, Sharp Packaging Solutions is an independent pharmaceutical contract-manufacturer and packer supplying a one-stop service for production and logistic for packaging tablets in blisters or patient packs and the production and filling of fluids and powders.
Sharp Packaging Solutions stands for quality, reliability, and flexibility in manpower, machinery and mentality delivering global coverage.
There are two dedicated production plants in The Netherlands, Production takes place in these modern facilities. Plants are specifically designed for pharmaceutical production.
For questions please contact Mr M. Dijkstra, Recruiter, Start People on the following number:
+31-618343611. Please send your response to: email@example.com