CMC & Quality Specialist (m/w/d)
CMC & Quality Specialist (m/w/d)
CMC & Quality Specialist (m/w/d)
CMC & Quality Specialist (m/w/d)
Alliance Medical RP GmbH
Pharma, Medizintechnik
Bonn
- Art der Beschäftigung: Vollzeit
- 59.000 € – 71.000 € (von XING geschätzt)
- Hybrid
- Zu den Ersten gehören
CMC & Quality Specialist (m/w/d)
Über diesen Job
Über uns:
At our site in Bonn, a team of around 40 dedicated experts develops and produces state-of-the-art PET tracers that significantly improve patients' lives. We combine scientific precision with a pioneering spirit - in an open, international environment where you can take ownership, drive innovation, and truly make an impact. Join our growing team and help shape the next chapter of our success story!
Wir sind ein Team von hands-on arbeitenden und kreativen Köpfen, die die Herausforderungen in unserer kleinen, innovativen Umgebung mit familiärer Atmosphäre schätzen. Geführt von unserem internationalen Umfeld liefern wir von 9 Standorten in 3 Ländern zuverlässig unsere hochmodernen Arzneimittel an Patienten, die von unserem nachhaltigen und expandierenden Service profitieren.
Aufgaben:
- Support current and new radiopharmaceutical development projects at the CMO.
- Assist in implementing and maintaining production processes and quality control testing.
- Perform risk assessments, using common concepts like, e.g., FMEA.
- Assess processes to be implemented from a quality perspective and ensure that implementation complies with internal and external quality standards and policies.
- Perform quality control testing (HPLC, GC, TLC).
- Perform validation activities (both operational procedures and computerised systems)
- Prepare / update, write, review, and approve GMP documentation.
- Track and report the progress of projects.
- Participate in regular internal project meetings to discuss and plan activities.
- Participate in regular meetings with contract organizations to provide project updates via teleconference or on-site visits, as appropriate.
- Maintain records documenting all relevant communications related to projects.
- Monitor project timelines and contracts for accuracy and follow up on any discrepancies with stakeholders.
- Collaborate closely with corporate Quality Assurance, Operations, and other departments within the organization to ensure alignment and effective communication across all project areas.
Qualifikationen:
- On-site work required.
- University degree in pharmaceutical sciences, chemistry, or a related scientific discipline.
- Advanced knowledge of GMP requirements.
- At least 2 years of experience in quality control (HPLC, GC, TLC) within the pharmaceutical industry.
- Experience in technology transfers and analytical method validation; experience in computer system validation will be an advantage.
- Experience in core tools of quality assurance (risk assessments, deviations, OOS, Change Control, CAPA)
- Experience in radiopharmacy will be an advantage.
- Ability to identify and solve critical problems.
- Creative mindset with the ability to think outside the box and challenge current CMC development strategies.
- Strong team player with excellent interpersonal and communication skills.
- Ability to communicate clearly and respectfully at all levels, consistently advocate for your objectives, and drive topics forward with commitment and determination.
- Willingness to travel and work within a remote, international team environment.
- Fluency in English and German
Wir bieten:
- YOU can expect that as an employee YOUR work, as well as that of all our employees, is valued in our global company operations.
- We believe that great people can do great work in a supportive, forward-looking environment.
- Flexible working hours and a performance-based annual bonus
- Up to 50% childcare subsidy for pre-school children
- SpenditCard (EUR30 per month) and access to corporate benefits
- 30 days of annual leave
- Subsidy for leasing an e-bike and convenient access to public transportation
- A responsible and varied role in a state-of-the-art production environment
- Comprehensive onboarding and training in all technical systems, including cyclotron and radiation protection technology
- Collaboration within a committed, professional, and friendly team