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- Qualified Person
About Our Client
Our client offers flexible and efficient packaging solutions to the pharmaceutical industry. They have modern production facilities that are specifically designed for pharmaceutical production.
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 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
- 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
- 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.
The Successful Applicant
- A 3rd level Pharmacy degree qualification;
- Approved QP status and eligibility for the QP role is desirable;
- FDA experience is desirable;
- Evidence of Continuous Professional development desirable;
- Minimum 3 years relevant experience in the pharmaceutical industry in particular of which 1 year in a Qualified Person role;
- In depth understanding of GMP and QA systems are essential including interpreting current regulatory requirements;
- High level of spoken and written English.
What's on Offer
- Fixed term, 12 month contract;
- Excellent primary and secondary benefits.