Chargé de Qualification H​/F

Chargé De Qualification En CDI

Join a dynamic and diverse team! Your main missions will be the realization and maintenance of the qualified status, outside laboratories, of production equipment (packaging and/or manufacturing), utilities (fluid networks, HVAC...), and infrastructures (production rooms...)

In this role you will:

• Pilot and execute the commissioning and qualification (C&Q) activities for our investment projects. For this you:
• Establish the commissioning and qualification strategy (Commissioning and Qualification Plan).
• Pilot risk analyses and impact analyses.
• Write and approve commissioning (FAT/SAT) and qualification protocols: QI / QO / QP.
• Organize tests with cross-functional services (production, maintenance...) and execute tests.
• Write and/or approve commissioning and qualification reports: QI / QO / QP.
• Write deviation sheets, evaluate the impact of non-conformities, propose corrective actions and follow up.
• Ensure the maintenance of the qualified state by carrying out periodic reviews and requalification activities.
• Participate in regulatory inspections to present the dossiers for the activities concerning you.
• Develop standardization tools within the service.

Your profile:

• Your experience covers at least 3 to 5 years in the qualification of pharmaceutical equipment in a BPF Gmp environment with knowledge of quality standards applied to the pharmaceutical industry, information systems and current regulations (21 CFR part 11, BPF, CGMP...).
• You have experience in the qualification of packaging equipment (blister machine, cartoning machine,...) and/or manufacturing equipment (granulator, dryer, tablet press...)
• You are an Engineer or hold a Master's degree in mechanical, chemical, pharmaceutical or general engineering.
• Your level of English allows you to interact in meetings and manage technical documentation.

The plus points that will make the difference:

• Your rigor and technical aptitude.
• Your ability to collaborate effectively in cross-functional teams.
• Your concern for continuous improvement.

Our plus points that make the difference:

• A human-sized site in full development (building extension, arrival of many new equipment).
• A wide variety of equipment.

We are waiting for you!

About Elanco

International pharmaceutical group leader in the development of products and services improving the health of companion and farm animals. Elanco's development is based on strong and important values which are Integrity, Respect and Excellence.

The Huningue site, based in South Alsace, has more than 35 years of experience and know-how, it is specialized in the production of tablets for companion animals.

Do you want to join a friendly site with strong values, offering an attractive working environment?

Do you want to join a growing company with modern and efficient production tools?

Are you passionate about the pharmaceutical industry? Write to us!

Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status