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Quality & Validation Engineer (W/M/X)
vor 4 Monaten
We are currently seeking a Quality and Validation Engineer to join our Quality team to ensure GMP standards are met within our operations. As a Quality and Validation Engineer, you will play a key role in ensuring the quality of information reported in our systems and documentation, in accordance with current guidelines, compliance, and regulatory requirements.
Your Responsibilities:
- Review deviations within engineering events in quality systems to verify their acceptability and compliance with standard procedures and regulatory requirements. This includes conducting or approving relevant investigations, impact assessments (concerning the impact on equipment/product/material), and defining appropriate CAPA.
- Review and approve engineering-controlled documentation being revised.
- Review and approve requalification of cleaning in place/sterilization in place/temperature control units, as well as associated protocol deviations.
- Perform change control assessments from a Quality Engineering standpoint.
- Attend all relevant meetings to perform the above-mentioned tasks.
- Adhere to the escalation process.
- Ensure the completion of relevant training and software access management in accordance with current policies.
- Occasionally perform other tasks related to conventional quality oversight to support the team (e.g., continuous improvement initiatives, GMP tours of technical areas, etc.).
Your Profile:
- Technical and scientific academic background.
- Minimum of 2 years of operational experience in cGMP within a Quality Ops or Engineering department at a manufacturing site in the pharmaceutical, biotechnology, and/or sterile injectable products industry.
- Knowledge of quality standards (cGMP) and quality systems (deviations, CAPA, change control, training, documentation, etc.).
- Technical knowledge in maintenance, facilities/utilities, HVAC, and calibration is a plus.
- Proficiency in both French and English.
Our Corporate Culture:
- Agility: Thrive in a flexible, dynamic, and stimulating environment.
- International: Benefit from international collaborations and numerous mobility opportunities.
- Intrapreneurship: Get involved in side initiatives or develop your own business unit.
- Supportive Management: Receive personalized support throughout your professional journey.
Amaris Consulting is committed to diversity and inclusion. We encourage applications from all qualified individuals, regardless of gender, sexual orientation, race, ethnicity, beliefs, age, marital status, disability, or any other characteristic.
