Quality Manager - QA Operations, Pharma

Salary
Competitive
Posted
26 Nov 2018
Closes
26 Dec 2018
Ref
CRBG - QAOP
Contract Type
Permanent

Responsibilities:

  • To set up and management of assigned Pre-Approval Inspection projects related to the Phase II and III clinical trial programme
  • To plan, conduct and follow up investigator site, vendor, documentation, pharmacovigilance and internal systems audits in accordance with the applicable company SOPs under the direction of the CQA Manager
  • To participate in cross functional company GxP audits as required
  • To Report and present to clinical staff, clinical investigators and other hosting company personnel on potential findings identified during audits
  • To report serious quality issues or non-compliances that are detected whilst carrying out duties for Good Clinical Practice (GCP), and Good Clinical Laboratory Practice (GCLP) activities to the CQA Manager
  • To enter CAPAs, resulting from the audit performed, onto the SharePoint CAPA Log and follows-up with the CAPA owner regularly until the actions are resolved, ensuring that assigned CAPAs are closed out appropriately and in a timely manner
  • To act as a QA specialist providing support to key clinical development functions as required; contributing to the development of SOPs and providing advice on processes and audit references, according to applicable current regulations / guidelines
  • To provide QA review of company SOPs (updates or newly developed SOPs)
  • To write or update CQA SOPs/Guidelines/Forms/Templates as required
  • To provide mentoring, training and support to CQA staff and CQA Consultants
  • To assess competency of other CQA staff members and CQA Consultants where applicable
  • To act as CQA Operational Lead for assigned studies, and supervises the global consultants/contractors involved in conducting these studies as required, including scheduling/allocating audit and reviewing consultant/contractor audit reports
  • To assist with the preparation for and coordination of GCP inspections conducted by international regulatory authorities/external parties
  • To assist in promotion of quality awareness and quality improvement amongst company personnel and of clinical investigator site staff
  • To represent CQA at relevant meetings
  • To maintain awareness of applicable Regulations and Guidelines and communicate training needs to the CQA Manager
  • To execute additional tasks in order to meet departmental project-related or developmental/change objectives
  • To carry out their work in a way that will not adversely affect their own, or others', health, safety and security or the environment and reports any shortcomings

Requirements:

  • Strong clinical/pre-clinical research experience in a healthcare company, with demonstrated knowledge and experience of auditing/inspection techniques
  • A Bachelor's degree or equivalent in a scientific discipline
  • Quality assurance qualifications
  • GxP international regulations and guidance, with the ability to apply this knowledge to resolve day-to-day issues
  • European, United States and local (UK) regulatory requirements
  • Pharmaceutical regulatory standards in clinical research and international regulatory requirements for product registration
  • Experience of auditing Pharmacovigilance activities
  • Competency in use of electronic systems for management and tracking of audit reports, CAPAs
  • Previous clinical/pre-clinical research experience working in a Pharmaceutical or other regulated industry
  • Excellent interpersonal and communication skills (written and verbal) across a wide range of disciplines, especially the ability to communicate diplomatically and to work effectively in a multi-disciplinary team
  • Excellent attention to detail and the ability to identify the root cause of problems
  • Demonstrates a 'can do' approach
  • Develops and maintains positive working relationships with others

Similar jobs

Similar jobs