GxP Specialist

Location: Aberdeenshire  |  Aberdeenshire  |  Scotland
Sector: Life Sciences
Consultant: Life Sciences Team
Job Reference: CC - HQ01034
Salary: £50000 - £60000
Job Status: Permanent / Full Time

Job Title:             GxP Specialist

Responsible to: Head of Quality Assurance

Hours:                   35hrs per week, 9am – 5pm

Salary:                  £50k – £60k

Location:             Aberdeenshire

Job Responsibilities:

  • Accountabilities: (describe the primary duties and responsibilities of the role)
  • Assist in implementing and maintaining a comprehensive GCP compliant quality programme
  • Assist in setting the annual internal, vendor and project schedules
  • Act as QA Audit Manager for selected audits
  • Oversee and/or manage and/or conduct internal system audits, vendor audits and investigator site audits, as requested by the Head of QA
  • Oversee contract Auditors, providing first line of communication
  • Manage corrective and preventive action plans and follow up via an appropriate system and/or database
  • Oversee the management and tracking of corrective and preventive action plans derived from any source
  • Oversee Quality Issue Management ensuring escalated issues are appropriately recorded, followed through to successful resolution and the outcomes reported
  • 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 Head of QA coordinate Competent Authority facility GCP inspections and provide assistance for other GxP Inspections
  • Assist the Head of QA with the initiation, writing, review, approval, update and distribution of documents e.g. policies, standard operating procedures, and associated documents, to support the Company Quality Management System (QMS)

Education

Mandatory

  • Science degree or degree in Quality Management

Desired

  • Higher degree in science, medically related discipline or Quality Management

Experience

  • At least 10 years of relevant pharmaceutical or allied industry experience which includes at least 8 years of direct quality assurance or regulatory compliance experience
  • Involvement in hosting and/or preparing for, and responding to, regulatory inspections
  • Working knowledge of GCP/ICH and FDA regulations and guidelines and international regulatory practices and how these interface with other GxPs
  • Commitment and ability to handle high workloads and deadlines
  • Knowledge of Drug Safety/Pharmacovigilance advantageous