- Will have a
thorough knowledge of EU healthcare
legislation and quality requirements while demonstrating an effective
communication style appropriate to audience and situation.
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
- 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
- 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 behavior in all interactions and hold others to the same standards; comply with all laws, policies and regulations.
- A 3rd level
Pharmacy degree qualification
- Approved QP status and
eligibility for the QP role
- Evidence of Continuous
Professional development desirable
- Minimum 10 years relevant
experience in the pharmaceutical industry in particular of which 3 years are in
a Qualified Person role
- Sound Experience of
pharmaceutical production, primary and secondary packaging
- In depth understanding of
GMP and QA systems are essential including interpreting current regulatory
- High level of spoken and written English.
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: firstname.lastname@example.org