External Supply Operations Quality Manager

1 mese fa

Rome, Italia Randstad A tempo pieno

Randstad inhouse services, specialty pharma, is looking for a resource on behalf of Pfizer srl to be included in the Rome office in the role of External Supply Operations Quality Manager.

 

Responsibilities:

- The ESOQ Manager is accountable for providing quality assurance management of key

contractors for Pfizer and for assuring that the products supplied to our patients are

manufactured & tested in accordance with c-GMPs, the registration file and any

additional country specific requirements.

- This is highly independent position operating with minimal supervision, interacting with

high levels of management both at contract manufacturers and within Pfizer.

- (S)he will operate as spokesperson for ESOQ and will focus on developing relationships,

independently negotiating, developing and communicating Pfizer quality requirements

with contract manufacturers. 

- ESOQ Manager will have significant interactions with many internal business and

manufacturing organizations (e.g. External Supply, Regulatory, Technical Support,

Quality, PGS sites and R&D) and will lead virtually-based cross functional teams.

- Initiate, review and approve regulatory changes through Pfizer enterprise system (i.e

PDM) for changes initiated by or impacting ESOQ managed contractors.

- Provide support for the closure of the deficiency letters, CMC Commitments, Regulatory

requests for Renewals, New Product registrations and Post approval variations.

- Main point of contact for Global Chemistry Manufacturing & Controls (GCMC) dpt or

Local Regulatory Affairs in Pfizer Country Offices (Single market prods) for the regulatory

activities involving the ESOQ contractors.

- As the Regulatory Expert, participate in Virtual Site Operating Teams (VSOT) or similar

meeting for ESOQ managed contractors and if needed, participate in Site Quality visits at

the contractors.

- Support and Perform Lot Disposition for Biotech semi finished and finished products (if

applicable).

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