QA Advisor

One of our clients, a multinational company in the pharmaceutical industry currently requires a QA Advisor

Start: ASAP
Length: min. 6 months
Location: South of Brussels

Key responsibilities:

- Coordinate, Organize and conduct Quality Assurance audits in internal and external labs partners to R&D with the aim to assess the degree of compliance with GxP (GCP, GCLP, GSP, GMP) principles andthe client's policies related to manufacturing and testing of vaccines.
- In operational priority, perform external and internal audits of laboratories involved in clinical testing activities and oversee the audit activities primarily within the GCLP auditor team and within

the QA Department.

- Coordinate, organize and conduct Quality Assurance audits in internal and external clinical laboratories that run various types of serological and immunological assays for the clinical trials with the aim to assess the degree of compliance with GCLP Principles andthe client's policies related to clinical trials.
- Ensure harmonization of audit expectations for all internal and external laboratories involved in the clinical studies

The audit activities include:

- Coordinate with teams on projects involving external testing
- Schedule on a 3 month basis the audit planning in collaboration withthe team.
- Audit preparation: contact the lab, define agenda and expectations.
- Perform full or partial system audits (as lead- or participant auditor).
- Write audit reports and perform findings analysis.
- For audits, ensure the escalation of critical issues through executive summaries for the management and feedback to the relevant teams.
- Carry out the peer review of audit report of the team.
- Follow-up of the audited laboratories in order to assure that the CAPA proposed by the process-owner, are being properly implemented.
- During third party audits (Corporate, Authorities) prepare, take part in the inspection and answer to inspectors if needed. Help to respond to the findings and implement CAPA.
- Management of the activities of the audit team.

The tasks include:

- Organization of the audit planning (in terms of human resources, timing, feedback to give within the company)
- Identification of the person in charge of each audit (Lead auditor) in line with the cost saving view of the company.
- Responsible to maintain the same level of requirements within the whole team in respect with the company's policy and throughout the time.
- Responsible to have a list of laboratories involved in clinical testing activities updated on a regular basis.
- Write, approve, issue or take part in thecreation/revision of Quality Assurance documents such as Standard Operating Procedures and Guidelines to improve quality continuously in the field of the audit activities.
- Report to management, team activities and highlights through a monthly report.
- Ensure communication with GQC at a corporate levelto share the audit planning, audit reports and general informationlinked to the audits.

Education:

Graduate in scientific or pharmaceutical engineering, industrial technology, chemistry or biotechnology or equivalent acquired through professional experience.

Knowledge:

- Knowledge of compliance rules (GCLP and other quality system like GCP, GLP, GxP).
- Knowledge of R&D environment is a plus.
- Experience in audit an asset.
- Fluent in spoken and written English both scientifically/technically as well as conversational.

Experience:

- Min 10 - 15 years of experience in Quality or Compliance environment in a Pharmaceutical or Biotech company.

Tags: QA, Quality Assurance, Assurance qualité, R&D, Pharmaceutical, Pharmaceutique, CAPA, Audit