Global Quality Auditing – Business Operations Partner
Contracting – Brabant-Walloon
Responsibilities?
- Monitor the progress of plans and projects, GQA performance, and compliance through
- meaningful KPIs. This will boost operational efficiency and agility. Ensure and track appropriate
- data entry performance of audit reports and CAPAs in the Veeva audit system.
- Enable insights for the company through data collection, entry, and analysis in the audit
- management tool (e.g., trending, KPIs, etc.).
- Curate data, including quality checks of audit management tool as needed, for
- KPIs/metrics on performance and information on trending.
- Ensure maintenance and improvement of quality of critical data within the Quality
- Management System (includes data entry of audit related information and data
- monitoring).
- Make extractions from the audit management tool for data inclusion within internal
- reports as well as to meet Health Authority requirements (e.g., Pharmacovigilance
- System Master File (PSMF)
- Act as a key point of contact in Global Quality Auditing & Compliance team for the audit management tool.
- Provide support to the Global Quality Auditing team regarding Documentation management within the controlled documents system.
- Identify improvement needs and implement consistent quality processes and systems across auditing quality units to promote standardization and simplification, thereby enhancing efficiency.
- Propel positive change and improvements across the auditing units by enhancing people's skills and processes.
Your profile?
- Master Degree (preferred) or Bachelor’s Degree
- 3-5 years of experience in the pharmaceutical/biotechnology area and/or Quality-related areas.
- Experience in the pharmaceutical industry within regulated areas (e.g., Research, Laboratory, Clinical, Pharmacovigilance, Manufacturing, …) and/or Quality Assurance expertise is a plus.
- Experience with Qlik Sense, Sharepoint, Teams, Veeva Systems is preferred.
- Fluent in English
- Regulatory & Technical Knowledge: Must be highly knowledgeable in the global pharmaceutical industry, including the interpretation and application of applicable GxP regulations in complex situations, knowledge of current and future trends in the industry and a deep understanding of major competitors/industry peers.
- Demonstrates curiosity and learns from the experience of success and failure
- Proactively shares knowledge with others in order to affect continuous improvement.
- Takes initiatives and works towards delivering results
- Challenges self and others on value creation
- Encourage quality mindset, constructive and holistic approach
- Ability to anticipate, influence & apply regulations to Quality Management System to ensure effective interpretations that support decision-making on current and future solutions to improve patients’ lives.
- Ability to independently and critically evaluate quality management systems and quality operations in support of Quality culture and operational output, balancing weaknesses against requirements and expectations.
Our offer
Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way. You’re interested in this job? We kindly invite you to apply or send me your CV, [email protected]
