Sterility Assurance Coordinator

This will result in a sustainable e-functional organization ensuring business continuity, alignment within the parenteral lines, and the secure rollout of the Sterility Assurance excellence program. Furthermore, this figure will guarantee the coordination and implementation of projects coming from the Parenteral Network alignment streams as well as key changes on the line impacting the sterility assurance strategy.

The Sterility Assurance Coordinator will report directly to the Sterility Assurance Associate Director and will daily manage the activities of the Sterility Assurance Scientist supporting the primary loop. The resource will also guarantee continuous support on the line as a backup of the primary loop sterility assurance representatives and will be a Flow team member (cross-functional team) to have an integrated governance and lean communication flow.

You will specifically support the following activities:

• Speed-up of technical troubleshooting of non-conformities emerged from day-to-day activities
• Ensure Sterility Assurance program execution. Manage in a timely routine protocols preparation/revision and ensure the right execution in terms of operations, documentation, and data integrity requirement
• Manage and coordinate small/urgent improvement projects (es. EM bag shortage, new gloves supplier)
• Process monitoring (site Sterility Assurance metrics, sharing EM report with field)
• Guarantee coordination with operations/utilities/ bio lab for activities concerning sterility assurance involvement (es. APS, EM sampling for EMPQ, Utilities related activities).
• Practices match Procedure program execution
• Alignment of the Sterility Assurance aseptic technique between the modules
• Maintain Sterility Assurance Excellence on the field
• He/she is responsible for performing the Sterility Assurance, supporting the preparation and ensuring readiness for any Regulatory inspection, and supporting the site inspection program.
• Coordinate and back up the Sterility Assurance Process Team member
• Share the mission, the vision of the company, and site objectives with collaborators
• Ensure effective communication is maintained between the primary loop and secondary loop
• Develops technical and relational skills of the collaborators
• Coach Tier 1

Basic Requirements:

• Master’s Degree (Scientific) Pharma, Biotech, and Microbiology Field will be preferred.
• Advanced knowledge of English (at least B2 CEFR).
• Very good Knowledge of aseptic processes and Sterility Assurance concepts.
• Very good knowledge of current GMPs, pharmaceutical legislation, and regulatory requirements.
• Strong interpersonal skills and attitude toward people management (team orientation, personnel development, etc)
• Relevant experience within the Process Team (Operation PT, LAB PT)
• Minimum of 4 years of relevant experience in the pharmaceutical parenteral industry

Additional Skills/Preferences:

• Strong problem-solving and organizational skills
• Decision-making attitude and stress management
• Excellent communication, people management, and interpersonal skills

What we offer:

Step into a role where your expertise is recognized, appreciated, and rewarded. As a member of our team, you can expect:

• Competitive Salary: We offer a competitive base salary supplemented by an annual variable component based on achieving objectives.

• Relocation Package: You will be eligible for a relocation package based on your location.

• Comprehensive Benefits: Enjoy a well-rounded welfare package, including an extensive insurance plan.

• Annual Salary Review: We recognize and reward your continued effort with an annual salary review, providing opportunities for advancement based on your performance. As part of our commitment to your future, you may also be eligible to receive a stock option package, aligning your success with the company's growth.