The Role
In the Synthetic Molecules Technical Development team (PTDC), you will contribute to the technical development of our synthetic molecule pipeline and the manufacturing of drug substances and drug products for clinical studies. PTDC brings a broad range of experience in drug substance, drug product, analytical sciences, and manufacturing science & technology, collaborating closely with partners in Research and Early Development as well as commercial counterparts.
As a GMP Compliance Specialist in the GMP Support & Compliance team of Operations Support & Compliance (PTDC-T), you will serve as a key figure ensuring compliance with Good Manufacturing Practice regulations across all aspects of our synthetic molecule pipeline, from research to commercialization.
Key responsibilities include:
* Developing and implementing GMP procedures and training programs to ensure compliance throughout the organization;
* Conducting audits and assessments to identify areas for improvement and provide recommendations for corrective actions;
* Collaborating with cross-functional teams to ensure alignment with regulatory requirements and industry best practices;
* Maintaining accurate records and documentation to support regulatory inspections and submissions;
* Providing expertise and guidance to colleagues on GMP-related matters and emerging trends in the field.
We are looking for an experienced professional who is passionate about ensuring the highest standards of quality and compliance in the pharmaceutical industry. If you have a strong background in GMP regulations, excellent communication skills, and a collaborative mindset, we encourage you to apply.