Qualified Person (remote-based)

Hobson Prior are looking for a Qualified Person to join a fantastic CRO on a permanent basis with remote-working available. Our client is focused on providing a range of regulatory, pharmacovigilance and technical services.

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities:

• You will be responsible for coaching and mentoring of the quality team to ensure understanding and successful implementation of quality systems.
• Acting as a subject matter expert to clients in the implementation and ongoing maintenance of quality systems.
• The ideal candidate will have the responsibility to provide QP certification and ensure all products certified are manufactured in accordance with GMP and the requirements of the marketing authorisation
• To evaluate batch documentation for product release.
• To conduct audits of outsourced manufacturing, testing or storage sites on behalf of the company, a related company and their clients.
• To carry out assessments of API manufacturing sites and to prepare QP declarations in support of regulatory submissions.
• To take an active role in the company's Quality management review.
• To ensure all complaints and deviations are thoroughly investigated and effective CAPA are implemented.
• To ensure any changes are adequately assessed for impact prior to implementation
• To support the regulatory function in the preparation and maintenance of regulatory dossiers including review of technical data and the preparation of expert statements to support variations.
• To provide GMP training to the company's staff and their clients.
• Any other duties reasonably associated to this position as assigned by the Board of Directors.

Key Skills:

• The ideal candidate must have good organisational skills.
• Excellent leadership and people management skills are required.
• You must be at Degree level.
• Hold a current Driving Licence.
• Thinks laterally outside own sphere of influence, suggesting ideas for improving company standards and systems, delivering against company objectives
• Is able to critically evaluate data and ensure that decisions are made on sound scientific judgement.
• Drives continuous improvement in company quality standards; ensuring leading edge results are produced.

Requirements:

• You must be eligible to act as a Qualified Person.
• The ideal candidate is required to have a minimum of 5 years experience within the pharmaceutical industry within a Quality function.
• A thorough understanding of current GMP and GDP requirements.
• Experience of implementing and managing quality systems in a GxP environment.
• Member of a recognised professional body.
• Ensures customers are aware of all current regulatory expectations and supports customers in achieving these aims.
• Can influence other functions both internally and externally to ensure ongoing compliance.
• Self-motivated and able to manage others to ensure business objectives are achieved.
• Proactively removes barriers and negativity both internally and externally, ensuring positive support for employees and company activities.
• Proactively organises and plans ahead, assessing long term requirements and potential future workload to ensure resource allocation and efficient, timely delivery.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.