Description
One of our clients, a multinational company in the pharmaceutical industry currently requires a QA Expert Start: ASAP Length: 6 months with a possible extension Location: South of Brussels
KEY RESPONSIBILITIES:
Organize and take the responsibility for Quality Assurance in GCLP (Good Clinical Laboratory Practice) activities for R&D Department:
- Make sure that Records, Standard Operating Procedures and documentation has been completed and endorsed by the staff authorized to do so.
- Approve master records, procedures, validation protocol and results & conclusions.
- Make sure that any deviations, OOS, changes have been authorized by the persons responsible in accordance with procedures.
- Assure the compliance to the Good Clinical Laboratory Practice and regulatory requirements in regards of the clinical laboratories from the client in Belgium.
* Ensure auditing activities and CAPA follow up:
- Participate to regulatory inspections: assure inspection
- Make sure that internal audits (self-inspection) are performed.
- Assure internal audits level 2.
- Make sure that commitments are followed up and implemented.
* Prepare and manage quality trend analysis/quality review/QA monthly report.
* Optimize and maintain the compliance level of the quality systems with regulatory, Corporate and the client's standards in R&D Belgian sites.
* Ensure a consistent approach to the interpretation and implementation of GCLP standards.
* Collaborate with and organize the work of the QA Technicians.
* Responsible to coach, train, develop, motivate and evaluate the QA Technicians through effective performance with KPI's as instrument
* Provide QA expertise and support to related teams
* Manage a team of QA Technical support.
Tags: QA, Audit, CAPA, Assurance Qualité, Pharmaceutical, Pharmaceutique