Qualified Person (QP)
A leading provider of integrated pharmaceutical development services to the global healthcare market is currently recruiting a Qualified Person (QP) to work at their office in South Wales.
- Supporting to the Quality Assurance Department in managing the QMS and assisting in quality investigations.
- Ensuring continued compliance, operationally, to the company's licences for Marketed Products, Investigational Medicinal Products and unlicensed medicines (Specials - as per company Bridgend (and/or Ireland) procedures).
- Customer satisfaction with service (internal and external).
- Reviewing Batch Manufacturing Documents to ensure compliance with EU GMP and the Product Specification File/marketing authorisation (or other where relevant).
- Reviewing Batch Documents for all operations performed at the company.
- Certifying Medicinal Products for use in the EU and outside the EU (where relevant).
- Undertaking audits in the EU and third countries to ensure that Sponsor or MA Holder manufacturing sites are operating in general compliance with EU GMP.
- Providing advice and guidance to the company's staff and customers regarding QP requirements within the EU.
- Keeping up to date with the requirements of the Medicines Authorities across the EU and rest of world (where relevant).
- Reviewing the company's Project Files (PSFs, commercial project files etc) to ensure compliance with the current regulatory requirements and company procedures.
- Providing input and assistance with relevant elements of the Quality Management System (QMS) at the company.
- Provide assistance with regulatory inspections and client audits.
- Agreeing and working towards the achievement of personal development goals
- Undertaking departmental tasks and projects outside the job holder's area of responsibility, in line with departmental and senior management team objectives.
- Deputising for the Lead Qualified Person.
- From time to time, the above listed duties may be undertaken at other company facilities, in particular, company sites located in Ireland. In such cases, the person will be responsible for ensuring they are properly trained in the local company site procedures and that their training record is maintained and up to date.
- The scope of the activities undertaken at the company is limited to projects managed or distributed from the company's facility currently and will assist company managed Brexit outcomes.
Skills and Requirements:
- Experience working as a QP in the certification of sterile medicinal products, in particular, Biopharmaceuticals manufactured aseptically.
- Eligible to act as a Qualified Person (QP) for the certification of Marketed Products and Investigational Medicinal Products in accordance with EU directives 2001/83/EC and 2001/20/EC respectively.
- Extensive QA experience within the medicinal products/ pharmaceutical industry.
- GMP audit experience, preferably qualified as Lead Auditor.
- Experience in Biopharmaceuticals.
- Experience in Sterile manufacture.
- Effective communication skills both verbal and written.
- Strong analytical thinking and problem solving skills.
- Customer service oriented.
- Self-confident, sound judgement and decision making skills.
- Self-motivated with drive to achieve outcomes.
- Trustworthy and conscientious.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
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 contact Joshua Godden at +44 203 854 0101 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.
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