Job description
Join our team as Process Validation Consultant and start a new adventure in an international and dynamic environment where you will be able to fulfil your career expectations in a fast-growing organization.
Being a consultant at Amaris Consulting means positioning yourself as a technical and functional expert in an industrial field but above all being an ambassador of our organization to clients thanks to:
Your interpersonal skills and ability to listen in order to build a strong relationship of trust with our clients and fully understand their challenges and issues.
Your curiosity and eagerness to learn as we support over 1000 clients from all sectors worldwide.
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Your missions
* Conduct risk assessment activities for sterile production processes.
* Support external suppliers in gathering information for drafting risk assessments.
* Review Commissioning, IQ (Installation Qualification), and OQ (Operational Qualification) protocols.
* Support threshold study activities related to visual inspection.
* Ensure equipment qualification aligns with CGMP standards.
* Supervise and provide guidance for sterile production process validation.
* Provide CGMP training to staff, ensuring regulatory compliance.
* Prepare updates for MS&T activities and share project progress during weekly meetings.
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Your profile
* Experience with CGMP and sterile production environments.
* Experience with qualification protocols: Commissioning, IQ, and OQ.
* Experience with process validation and threshold studies.
* Experience with risk assessment in pharmaceutical manufacturing.
* Academic background: degree in Life Sciences, Engineering, or related fields.
* Fluent Italian and English.
* You have strong analytical skills, attention to detail, and the ability to work effectively in a team environment.
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What we offer
* An international community bringing together 110+ different nationalities
* An environment where trust has a central place: 70% of our key leaders started their careers at the first level of responsibilities
* A robust training system with our internal Academy and 250+ available modules
* A vibrant workplace that frequently gathers for internal events (afterworks, team buildings, etc.)
* Strong commitments to CSR notably through participation in our WeCare Together program
* Remote policy: On-site project – no remote option available for this position
Amaris Consulting is proud to be an equal-opportunity workplace. We are committed to promoting diversity within the workforce and creating an inclusive working environment. For this purpose we welcome applications from all qualified candidates regardless of gender, sexual orientation, race, ethnicity, beliefs, age, marital status, disability or other characteristics.