QP

Employer
Hobson Prior
Location
England, Slough, Berkshire
Salary
£100 - £110 per hour
Closing date
1 Oct 2020

View more

Discipline
Quality, Qualified Person
Hours
Part Time
Contract Type
Contract
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Hobson Prior are looking for a Qualified Person to strengthen the European Regulatory Affairs department at a leading biopharmaceutical company on a contract, part-time basis.


Job Responsibilities:

Act as a Qualified Person in relation to MIA 39 according to GMP/GDP regulations, local laws and company procedures.

Carry out the Routine Duties of a Qualified Person as defined in MHRA Guidance on Manufacture and Importation.

Ensure Marketing and Manufacturing Authorisation requirements are met for batches to be certified.

Ensure GMP/GDP requirements are met.

Ensure principal manufacturing and packing processes have been validated.

Review of batch documentation and testing results for release to ensure compliance with release specification.

Review of change controls to ensure appropriate status for batch release.

Ensure all sampling and testing has been carried out as appropriate.

Make sure all batch documentation is suitably reviewed to ensure completeness.

Continually maintain suitable knowledge.

Ensure that a log is maintained for all batches certified.

Ensure suitable reference/retention samples are kept for the appropriate period in an appropriate location.

Take part in internal audits or external audits as requested or as appropriate.

Review and/or approve GxP documentation.

Undertake project work as directed by the Quality Lead.

Key Skills:

Good interpersonal and communication skills.

Current knowledge of requirements for GMP and GDP.

Requirements:

10 years' experience in the pharmaceutical industry.

Eligibility as Qualified Person (UK)

Bachelor's Degree.

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.

Providing recruitment solutions across the life sciences industry

Hobson Prior is a leading specialist life sciences recruiter focused on finding and placing outstanding candidates across Europe and the Asia Pacific. We work proactively and with integrity, communicate in a professional and honest manner and invest time to understand and match the exact requirements of our clients and candidates.

Our highly selective clients trust us to source and secure interim and permanent candidates who’ll make a real difference to the success of their business. Our candidates, the best in the industry, often choose to work with us exclusively because we offer the best opportunities in their specialist field.

Representing who we are and what we stand for, our values influence the way we serve our clients and candidates and the way we interact with each other.

We identified them collaboratively – as a team – and so feel 100% invested in them. Together, we think they provide the best possible outcomes all who work with us.

Professional
Our standards are set high. We work to a rigorous set of processes to ensure that our conduct is professional, ethical and delivered with integrity at all times.

Dedicated
We are dedicated to finding the very best solutions for our clients and candidates, always going the extra mile to deliver measureable value.

Experienced
We are guided by our experience and knowledge to provide the best possible service and support to our candidates, clients and colleagues. Our approach is consultative and collaborative.

Specialist
We focus solely on our chosen market, developing expert consultants who know their industry in depth and specialise within it.

Proactive
We find great candidates, developing relationships with them regardless of whether they are actively looking. This means we are able to provide both candidates and clients with unique opportunities.

Ambitious
Driven by results, we have plans to expand across different global regions and markets and have confidence in our ability to grow successfully through our core focus.

Contact Us
  • Wellington Gate
  • 7-9 Church Rd
  • TN1 1HT
  • GB
  • 01892 612 612
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