CMC & Quality Specialist (m/w/d)

Stellenbeschreibung:

Work at Alliance Medical RP means:
YOU can significantly contribute in YOUR individual work area.
YOU will work together and be hands-on with various departments and interest groups.
YOU can expect that as an employee YOUR work, as well as that of all our employees, is valued in our global company operations.
It doesn't matter whether you work in the office or from home – YOU are an important part of our closely connected community.
YOUR ideas and contributions will be recognized and YOUR personal and professional growth will be supported by our dedicated leadership team.
YOUR future at Alliance Medical Radiopharmacy lies in YOUR hands

Our team can't wait to get to know YOU

So there's only one thing left to do: Apply

Bonn - Auerberg

About us
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

Major Tasks

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

Benefits

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 (€30 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

Porfil

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

Über uns
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.