Oxford BioMedica (UK) Limited

Senior Quality Assurance Specialist, GCP/GLP Specalist

Location
Oxford
Salary
Competitive
Posted
26 Jul 2021
Closes
17 Aug 2021
Ref
OXB-QA-639
Discipline
Quality, QA / QC
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job description:
 

Do you pride yourself on your integrity? We do what’s right for employees, patients and partners, and so can you.

 

Oxford Biomedica’s Quality Assurance team is responsible for the companies quality processes and systems, in compliance with GMP, GLP and GCP guidelines.  The team are accountable for internal and external audits, quality compliance and control.

 

We are currently recruiting for a Senior QA GCP/GLP Specialist to join us to provide additional knowledge and capability to the QA Team.

 

Your responsibilities in this role would be:

 

  • Participate in the development, implementation, and maintenance of the company’s GCP & GLP quality management system and facilitate continuous improvement.
  • Provide GCP and GLP QA oversight and support to internal staff and represent QA on GCP & GLP Related project teams.
  • Develop and implement annual audit strategies, and quarterly GCP & GLP audit schedules.
  • Schedule, oversee and perform (either directly or via external auditors) routine and non-routine quality assurance audits to include, but not limited to: clinical investigator sites, animal testing sites, vendors, process, and system.
  • Assist in the selection of external auditors, coordinate audits, and associated documentation in a timely manner.
  • Support internal and external GLP testing to ensure compliance with guidelines, SOPs, protocols, and industry standards.
  • Conduct QA review of GLP methods, data and reports.
  • Assure/coordinate proper and complete resolution of findings/non-compliant situations in a timely manner, including approval of corrective action/preventive action (CAPA) plans, as necessary.
  • Conduct QA review of GCP protocols, ICFs, CSRs and other clinical trial specific documents.
  • Participate in the preparation and conduct of inspections and audits performed by regulatory authorities and other parties.

 

To be successful in this role, you will have the following skills and experience:

 

  • Bachelor’s Degree in a scientific discipline
  • A strong working knowledge of GCP, GLP and ICH requirements
  • Previous experience within Advance Therapeutic Medicinal Products (ATMPs)
  • Proven experience in the Pharmaceutical industry within QA
  • Strong verbal and written communication skills
  • Excellent organization and multi-tasking skills
  • Ability to think strategically in order to improve current processes
  • Ability to work independently and prioritise with minimal supervision
  • Ability to work effectively across a matrix organisation

 

Do you want to feel inspired every day?  We’re future-focused and our business is growing rapidly. We succeed together through passion, commitment and team work, and so can you.

 

Collaborate. Contribute. Change lives

 


Profile description:

 

 

 

To be successful in this role, you will have the following skills and experience:

 

 

  • Bachelor’s Degree in a scientific discipline
  • A strong working knowledge of GCP, GLP and ICH requirements
  • Previous experience within Advance Therapeutic Medicinal Products (ATMPs)
  • Proven experience in the Pharmaceutical industry within QA
  • Strong verbal and written communication skills
  • Excellent organization and multi-tasking skills
  • Ability to think strategically in order to improve current processes
  • Ability to work independently and prioritise with minimal supervision
  • Ability to work effectively across a matrix organisation

Do you want to feel inspired every day?  We’re future-focused and our business is growing rapidly. We succeed together through passion, commitment and team work, and so can you.

 

Collaborate. Contribute. Change lives

 


We offer:

 

 

 

We are committed to offering highly competitive reward packages for all our staff. That’s why, every year, we benchmark our salaries and benefits against the local pharmaceutical market – by that, we mean that we compare our packages with those of other major companies in the London, Oxford, Cambridge areas.

We’re looking for highly skilled, focused individuals to help us deliver life-changing therapies to patients. It’s no mean feat, and we have to work together to make this happen.

Along the way, you’ll have a rich variety of opportunities to really develop your career. We’ll also give you a generous set of employee benefits and a competitive salary.

 

 

Similar jobs

Similar jobs