Job Description:
We are seeking a skilled and detail-oriented Deviation Writer to join our Quality Assurance team. The ideal candidate will be responsible for documenting and managing deviations in compliance with regulatory requirements and internal policies. This role is crucial in ensuring that all deviations are thoroughly investigated, documented, and resolved in a timely manner.
Key Responsibilities:
* Write, review, and manage deviation reports in accordance with company policies and regulatory standards.
* Conduct thorough investigations of deviations, identifying root causes and corrective actions.
* Collaborate with cross-functional teams to ensure timely resolution of deviations.
* Maintain accurate records of deviations and ensure proper documentation practices.
* Assist in the development and implementation of training programs related to deviation management.
* Support audits and inspections by providing necessary documentation and explanations.
Qualifications:
* Bachelor’s degree in Life Sciences, Pharmacy, or a related field.
* Minimum of 4 years of experience in a pharmaceutical or biotech environment, with a focus on quality assurance or deviation management.
* Strong understanding of regulatory requirements (e.g., FDA, EMA) and quality management systems.
* Excellent writing and communication skills, with a keen attention to detail.
* Ability to work independently and collaboratively in a fast-paced environment.
* Proficient in Microsoft Office Suite and quality management software.
Why joining us:
* Rapid growth: Amaris has doubled its workforce in Belgium in two years, providing numerous growth opportunities for employees.
* Prestigious projects: Candidates will work with renowned clients in the pharmaceutical, biotechnology, and European institutions sectors on impactful missions.
* International environment: An agile and dynamic structure promotes intrapreneurship and meritocracy, with international exposure at the heart of Europe.
Amaris Consulting is proud to be an equal opportunity workplace. We are committed to promoting diversity within the workforce and creating an inclusive working environment. For this purpose, we welcome applications from all qualified candidates regardless of gender, sexual orientation, race, ethnicity, beliefs, age, marital status, disability, or other characteristics.