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QA Consultant
il y a 1 mois
We are a service provider company, leader in the Pharmaceutical and Medical Device sectors since 1998, with more than 1500 employees, 45+ nationalities and 28 subsidiaries all over the world (Europe, Asia and the Americas). Joining PQE means being a part of a multicultural and challenging company, with many local and international projects, and colleagues from all over the world.
Due to a constant growth, PQE is looking for a **Quality Assurance Consultant** to join our **QA Team in Belgium**.
Working in a consulting reality as PQE Group will give you the chance to work on projects for the most important national and international pharmaceutical companies. This opportunity will allow you to travel up to 50% of the time in Belgium and Europe to visit our clients’ sites and quickly increase your professional experience thanks to the constant support of a multicultural team of expert consultants and continuous on the job training.
**Responsibilities include, but are not limited, to the followings**:
- Conducts Minor / Major / Critical Deviation investigations in their respective areas as necessary and documents such investigations appropriately
- eads Root Cause Analysis to identify the most probable root cause, determine product impact, and assign appropriate CAPAs with responsibilities and due dates
- Performs trending to identify and report adverse trends that may require further action
- Completes investigations within the specified time-frames
- Develops corrective and preventative actions to prevent problem recurrence and establishes an effective follow-up system to ensure corrective and preventative actions have been implemented and are effective
- Reports performance metrics to Project Leader on a periodic basis
**Requirements**:
- 1+ years experience in pharmaceutical industries related to Quality Assurance activities (such as management of PQR, Auditing, Change Control, Complaints, Deviations, CAPAs, Batch Record reviews, SOPs, training, Qualification and Validation, etc.)
- Expertise in a sterile environment
- General knowledge of Pharmaceutical processes
- Expert in executing Risk Assessment (e.g. Process, Cross-Contamination)
- Fluent English (at least B2/C1 Level)
- Full availability to travel domestically and abroad (at least 50%)
Our collaborators are engaged, developed, challenged and well-rewarded for performance. We recognize the importance of leadership at all levels of our organization in order to succeed in a challenging business environment, and we are committed to providing practical processes and programs to identify, develop and inspire all our current and future leaders.
