Due to continued growth, PPD is hiring a QA Specialist for our Central Labs business in Zaventem. This position provides technical support to the Project Team. Responsibilities:
- Represents QA in area of expertise to include performance of internal and/or vendor audits, participation in client or regulatory audits and participation in inter-departmental meetings related to the area of expertise.
- This may include responsibilities for instituting and administrating systems for tracking of laboratory investigations, non-compliance or deviations and the corrective and preventative (CAPA) action plans that result.
- Participates in training activities and contribute to policy making decisions as a resource in area of expertise.
- The QA Specialist is expected to be able to perform QA Auditor II duties.
- Participates in client and regulatory inspections/audits and represents QA and follows up on audit issues and corrective action
- Participates in inter-departmental meetings and contributes to policy-making decisions
- Provides training for QA and/or laboratory staff
QualificationsEducation and Experience:
- Bachelor’s Degree preferred or good general education, combined with evidenced administrative competence and relevant IT skills.
- General experience preferably in clinical research.
- Self-motivated, positive attitude with effective oral and written communication and interpersonal skills
- Ability to work in a team or independently, as required
- Good organisational skills and strong attention to detail, with proven ability to handle multiple tasks efficiently and effectively
- Demonstrated ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency
- Strong customer focus
- Flexibility to reprioritise workload to meet changing project timelines
- Demonstrated ability to attain and maintain a good working knowledge of applicable FDA Regulations, ICH Good Clinical Practices, College of American Pathologists requirements and PPD/Client SOPs and WPDs for all non-clinical/clinical aspects of project implementation, execution and closeout.
- Strong English language and grammar skills
- Strong computer skills, proficient in MS Office (Word, Excel, and PowerPoint) and ability to obtain knowledge and master all clinical trial database systems
How to apply: Please submit your CV in English.
PPD is Equal Opportunity Employer.