Company Jobs

The Quality Manager responsible for handling technical complaints is tasked with investigating and managing technical complaints raised by clinical investigator sites regarding Investigational Medicinal Products and Medical Devices. Support data integrity incidents, manage escalations, and contribute to global DI networks and initiatives.

Work with the Team to achieve and exceed targets within the frame given by the Group Leader and Team Leader of Process Innovation. Keep self updated on the state of the art in synthetic chemistry development and techniques, while putting specific focus on innovative process research

Plan, implement and evaluate experiments for establishing of composition, manufacturing procedures and packaging via support of def. evaluation experiments taking product stability, bioequivalence and possible production site into consideration.

eCTD Compilation, validation, and submission to Health Canada and US through ESG gateway for New Submission ANDS, NDS, Deficiencies response Clarifax, SDN, NOD, NON, Supplements submissions

Able to conceptualize and design novel vectors across expression systems including bacterial, yeast, mammalian, gene modification techniques. Experience in mass spectrometry for protein, antibody analysis.

Verify the accuracy of transcribed data by cross-referencing with original sources and ensure an accurate presentation of data in the report. Ensure that all transcribed data complies with internal quality standards and external regulatory requirements.

Conduct in-depth research and analysis of rare disease markets, including competitive landscape, market dynamics, and emerging trends. Develop and maintain a comprehensive understanding of the rare disease market, including key players, product portfolios, and future opportunities. Collaborate with cross-functional teams to gather and synthesise relevant data and insights to support strategic decision-making.

QA Specialist will serve as QA technical subject matter expert for CSV process, such as MES, KNEAT, DCS, including but not limited to GMP enterprise systems, manufacturing systems and computerized equipment, laboratory systems and computerized equipment and validation software tools.

Represent Regulatory Affairs as team member of product development projects from Concept through Commercialization. Review pre-clinical, and clinical protocols and associated reports to be used in submissions for assigned projects.