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Qualified Persons

Employer
Entrust Resource Solutions
Location
Oxford, Oxfordshire (GB)
Salary
Competitive Salary
Closing date
6 Feb 2022

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Job Details

What will you do? 

  • Execute Qualified Person (QP) responsibilities, duties, batch certification and disposition as defined in 2001/83/EC, 2001/82/EC, 2011/62/EU and Eudralex Volume 4, Annex 16. If the product is to be released to the US market, all appropriate cGMP's requirements as defined is US. “CFRs” and other relevant regulations should be complied with.
  • Ensure that products are manufactured in accordance with GMP, site procedures and applicable regulatory requirements.
  • Maintain a thorough and up to date understanding of international regulatory guidance, corporate and client requirements pertinent to the site, and to ensure that all work within the site complies with these and with site procedures.
  • Take actions necessary to maintain and extend their technical and professional competence and to ensure that they have a thorough understanding of any new product or process prior to conducting any QP batch certification and disposition.
  • Represent at client meetings, providing GMP/regulatory guidance as appropriate 
  • Host client and regulatory inspections, undertake regular internal audits, self-inspections 
  • Undertake and support investigations, root cause analysis and review & approve Major/Critical deviation, Complaints and any change proposals with process/product impact.
  • Undertake and support the QMR process.
  • Undertake and support the implementation of Operation Excellence by encouraging peers and stakeholders to identify, lead and implement improvements.
  • Act as change agents by gaining support for and driving sustainable improvements to ways of work
  • Proactively ensure continuous improvement of the QMS and that it is inspection ready and maintained in a state of control
  • Proactively drive and react to system trending (e.g. deviations, complaints and environmental management) to ensure ongoing quality performance and improvements.
  • Establish and maintain effective communication with clients to match internal and external client expectations

How will you get here?

  • Understand and ensure implementation of emergency procedures and safe systems of work.
  • Ensure compliance with environment, health and safety rules, signage and instructions at all times.
  • Ensure prompt reporting and investigation of all accidents, near misses and breaches of rules.
  • Minimum Degree in Chemistry, Pharmacy or Microbiology
  • Minimum 5 years experience working in a pharmaceutical quality function, ideally within a development site and with knowledge of Oral solid dose drug products
  • Experienced in executing ‘Qualified Person’ responsibilities and duties as defined in 2001/83/EC and 2001/82/EC (as amended)
  • Up to date knowledge of the principles and guidelines for GMP as set out in: UK “Orange Guide”, EU “Eudralex Volume 4”, U.S. “CFRs” and other relevant regulations.
  • Excellent scientific and technical knowledge
  • Pre-requisite for this job is that the candidate is not on the “FDA DEBARMENT LIST”
  • Capable of working to deadlines and prioritize multiple tasks
  • Excellent written and verbal communication skills to internal and external stakeholders
  • Flexibility to meet changing needs and priorities of the business
  • Pragmatic, well organised with logical and methodical approach to work
  • Leadership experience and the have the strength of character to guide cross-functional teams of professionals

Please send your CV to hardev@entrustrs.com. We are an equal opportunity employer

Company

Entrust Resource Solutions (ERS) is a resourcing group comprising of three like-minded consultancies operating within the life sciences, healthcare and technology industries Globally. – Entrust People Ltd – Horton International UK Ltd – SCI Search and Selection Ltd

Finding the best talent in the market is critical to the growth and ongoing improvement of every business. We help our clients navigate talent demands from bench to board with our tailored search and resourcing solutions. With our in-house knowledge of the life sciences industry, we have developed a consultative, proactive and creative recruitment solution for our clients across the UK, Europe & US. We tailor our strategy to best suit the needs of each individual client, working with them to understand their current and future growth plans. 

We specialise in the following disciplines across UK wide Life Science / scientific sectors :-

  • Research and Development - Analytical Chemistry, Toxicology, Drug Discovery, Formulation, Process Chemistry, Quality, Validation, Project Management, Synthetic / Organic Chemistry
  • Pharmaceutical Development - Clinical Development, Clinical Operations, Medical Quality, Data Management, Regulatory Affairs, Safety, Bio Statistics
  • Technical Support - Manufacturing, Engineering, Supply Chain, Quality Assurance, Quality Control, GMP Operations
  • Commercial - Manufacturing, Engineering, Supply Chain, Quality Assurance, Quality Control, GMP Ops

Our talented team of scientists and life science experts have a wealth of experience across the UK and European markets. From our three offices across the UK, we service roles from bench to board, supporting your full hiring needs, including executive search, permanent and contingent talent planning.

We manage the full hiring process, reliably and comprehensively, until a successful placement is made. We offer our clients a first-class service, from understanding your current and future hiring plans and comprehensive candidate searches, to timely and relevant CVs for interview consideration and offer negotiation, all with regular communication on our progress.

For candidates, we offer an unparalleled understanding of their industry and intended career progression, enabling us to secure the best fitting roles available in the industry.

Website : www. entrustrs.com

Phone : 01224 907990 / 01606 818290

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Website
Telephone
01224 907990 / 01606 818290
Location
Head Office
River Court
5 West Victoria Dock Road
Dundee
DD1 13JT
United Kingdom
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