Administratively supporting Italian Account managers, service managers in their operational activities in SAP, tender reviews, business and legal approvals, documentation support and coordination.
**Key Responsibilities**:
Provide effective support to the Sales teams, Service teams, Business partners and other customers in Italy.
Driving/owning alignment meetings with Account managers/Service to drive on time submission.
Tender and RFQ review and submission, actively follow up on approvals and ensure completeness of Contract administration records in SAP.
Within the work of assemblying capital equipment documentation, this individual must understand mechanical drawings, component designs, electrical schematics, vendor test protocols, and 3rd party material certifications to move the work forward. These documents will be combined to create equipment turn over package used for factory acceptance testing and Site acceptance testing. These document packages may be review by the FDA prior to start of client drug manufacturing.
At least 5 years of experience in a GMP regulated industry, preferably biotech, pharmaceutical, or medical device 2 years minimum experience in Quality Assurance, preferably Supplier Quality Experience in working as a part of a cross-functional team. Experience in working with internal and external partners to assure compliance, remediation of issues by CAPA and continuous improvement of quality systems and business processes. Experience with key elements of the Quality system including change control, deviations and CAPA. Experience in writing, reviewing and approving GMP documents such as SOPs, Directives, etc.
Request and drive bank guarantees and bid bonds.
Ability to work well independently and in team environment. Excellent interpersonal, communication and organizational skills. Strong accuracy and attention to detail. Ability to multi-task, meeting tight deadlines in a fast paced environment. Experience with Microsoft Word and Excel. Strong interpersonal oral and written communication skills. Familiarity with Good Manufacturing Practices. In this role it is essential to perform shift work. Demonstrated commitment to our fundamental principles of Integrity, Respect & Excellence. Proficiency with the English language. Experience with SAP (an asset).
**Qualifications**:
High school diploma
Good knowledge of Office packages, such as Outlook, Excel and Word
- Excellent verbal and written communication skills