Kelly Clinical & Science, for a leading pharmaceutical company, is looking for:
SENIOR SPECIALIST INTERNATIONAL FILL FINISH - PERSON IN PLANT
Reporting to the Director, International Fill Finish, the International Fill Finish Senior Specialist is a newly created position and will have the opportunity to collaborate in the definition and buildup of the External Manufacturing Fill Finish function in Italy for pharmaceutical multinational.
The International Fill Finish Senior Specialist will liaise with Company's International Fill Finish Contract Manufacturing Organizations (CMOs) to ensure on-time and in-full deliveries. This includes supporting the Director, International Fill Finish Operations to ensure all operational related activities at the Fill Finish CMOs are conducted to meet all of Company's requirements. This role will collaborate with other functions locally and abroad to continue to execute on Company's production strategy.
Here's What You'll Do:
Support the Director, International Fill Finish Operations in various tasks related to the buildup of GMP production at Fill Finish Contract Manufacturing Organizations (FF CMOs).
Act as a counterpart for FF CMOs team members to ensure on-time and in-full deliveries. Partner with Quality, Technical Development, Manufacturing Science and Technology, and Regulatory colleagues on specific aspects of the relationships with the FF CMOs.
Ensure operational related activities at the FF CMOs are conducted to meet Company's requirements (Compliance, Meeting Orders, Dispute resolution, Production Planning, Materials Management, Technology Issues, OpEx).
Ensure externally manufactured drug products are produced and stored according to the appropriate documentation in order to obtain the required quality.
Ensure that instructions relating to external production operations are strictly implemented by the CMOs
Ensure in collaboration with quality that the appropriate qualification, maintenance, trainings and validations are performed to meet the appropriate Company requirements.
Support and perform the reviews for process performance at FF CMOs.
Monitor Key Performance Indicators of FF CMOs.
Support preparation of periodic business and operations review meetings.
Drive for and implement agreed continuous improvements at FF CMOs.
Coordinate reviews and approvals of various documentations from FF CMOs.
In collaboration with Quality coordinate investigations and troubleshooting efforts at FF CMOs
Write or revise the appropriate GMP documentations.
Frequently visit and maintain presence at the external partners' sites and build strong interdependent relationship with the CMO Counterparts in order to assess the as is state & risks for action-oriented improvement plans.
Performs other administrative duties as required.
Here's Who are looking for:
Bachelor's Degree with 5-8 years of experience in biopharmaceutical operations or a Master's Degree with 2-5 years industry experience; Degree in Engineering or Life Sciences is preferred
Fluency in English and Italian are required
Good communication skills (verbal and written) to collaborate with other CMC team members and managers in a dynamic, cross-functional matrix environment
Ability to work with members of partner organizations (CMOs)
Well organized - a natural ability to be organized in how you think, communicate and conduct your work
You drive for results - you set a high bar for yourself and others
Good critical thinker that can anticipate the needed next step and therefore can work independently
A curious mindset that allows you to constantly learn and challenge the status quo
Ability to navigate through ambiguity and rapid growth and adapt to change.
Here'e What we offer:
Salary to be defined according to the level of experience.
Kelly Services S.p.A., iscritta in data 26/11/2004 nell'Albo Informatico delle Agenzie per il Lavoro, Sez. I., prot. n. 1098-SG. I candidati ambosessi (L. 903/77) sono invitati a leggere sul sito www.kellyservices.it l'informativa sulla Privacy (Regolamento UE 2016/679).
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