Job Responsibilities
1. Support the release and stability strategy, method validation, and method transfer activities for our products covering development activities.
2. Support the operational aspects of GMP testing of Biologics clinical drug substances (DS) and drug products (DP).
3. Independently manage activities and provide required documentation according to agreed timelines and standards.
4. Responsible for the successful delivery of work packages to support GMP testing of Biologics clinical drug substances (DS) and drug products (DP) for release/stability/validation/transfer.
5. Author and/or review technical source documents in accordance with project timelines for global submissions.
6. Review high-quality CMC documentation for HA submission.
7. Conduct instrument qualification/decommissioning as System Owner and support our shipment desk as Sample Management Officer.
Qualifications
1. Well-developed planning, organizational, problem-solving, and interpersonal skills.
2. Good communication skills with a collaborative and patient-focused mindset.
3. Computer/IT systems literacy.
4. Science degree (e.g. Chemistry, Pharmacy, Biochemistry, Molecular Biology, Biotechnology, Biology) or equivalent - advanced degree desired.
5. Couple of years of Quality Control experience in a GMP environment and/or pharmaceutical industry experience.
6. Sound technical and scientific knowledge of pharmaceutical development and analytical sciences.
7. Knowledge of health authority regulations.
8. Proven ability to critically evaluate data from a broad range of scientific disciplines.
9. Proficient in English (other languages are a plus).
Company Overview
A very renowned pharmaceutical company with an international work environment.
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