GVP Quality Assurance Expert

Discipline: Quality Assurance
Job type: Permanent
Contact name: Katie Dunbar

Contact email: katie.dunbar@rbwconsulting.com
Job ref: 27012
Published: about 1 year ago
Expiry date: 26 Jul 2023 11:59

RBW are partnered with a pharma company to support the growth of their Quality Assurance team.

They are currently seeking someone to lead Quality activities related to Pharmacovigilance, including audit planning and execution, and review of PV related QMS documents.

This is an awesome time to join the company, as they have a pipeline of trials from Phases 1-3, so you will have input across the whole gamut of PV QA activities, as well as an opportunity to develop your understanding of GCP.

 

It would be your job to assess PV quality related metrics to ensure that satisfactory CAPA plans are established, monitored, and confirmed. You will be a PV QA Subject Matter Expert, providing PV quality related guidance to the company and supporting other QA team members in ensuring that appropriate systems, processes, and documented procedures are in place.

 

Key Accountabilities:

  • Assist in implementing and maintaining a comprehensive GVP compliant quality programme.
  • Drive PV risk-based assessment, establishing risk-based PV audit strategy, and implementation of this within the annual audit schedule, acting as QA audit manager for PV and other assigned audits.
  • Provide QA review and assessment of PV related deviations and follow up to closure of all QIs or CAPAs associated with these.
  • Perform audits of regulatory required documents e.g. study protocols and subject informed consent forms and conducts investigator site, vendor, and internal audits to assess compliance with study protocols and cGxP, as required.
  • Assist the QA Director to coordinate GxP Regulatory Authority inspections (including GCP site inspections).
  • Assist with the initiation, writing, review, approval, update, and distribution of documents e.g. policies, SOPs, and associated documents within your SME area, to support the QMS.
  • Maintain awareness of, interpret and operate according to current and new GxP regulations and requirements into systems, processes, and procedures, as applicable.
  • Assist with the review of vendor SOPs, to ensure consistency and applicability with regulatory and internal requirements.
  • Provide consultancy to employees on all QA, GxP and Quality Management issues, and prepare and conduct GVP training
  • Escalates any significant compliance issues relating to the PV system or GxP compliance to the attention of the Development Management Committee, providing feedback and suggestions for process improvement
  • Act as QA representative for PV related computer system validation activities.

 

 

Essential Experience:

  • Undergraduate degree in science, nursing, life sciences or Quality Management.
  • Considerable pharmaceutical industry experience, including direct quality assurance or regulatory compliance auditing. nm
  • Knowledge of Drug Safety/Pharmacovigilance.
  • Working knowledge of GVP, GCP and ICH and how they interface with other GxPs.
  • Expertise in MHRA, EMA and FDA regulations and guidelines.
  • Commitment and ability to handle high workloads and deadlines.
  • Regulatory inspection experience (hosting/participant/interviewee) is advantageous.

 

My client offers a competitive salary, negotiable based on experience, excellent working conditions and a fulfilling and rewarding career, with plenty of opportunities for further development.

 

This is an immediate employment opportunity and could be on a full-time or part-time (75%) basis, and could be considered on a contract or permanent basis. The office is in Aberdeen, but this role can be remote from anywhere in the UK, working from home with monthly trips to the office (with travel and accommodation costs paid by the company).

 

If you have the essential skills required and would like to discuss the full detail of the Job Description, required competencies, and remuneration, please contact Katie Dunbar on +441293 584300, or apply with your CV to arrange a confidential discussion.