External Supply Operations Quality Manager (Fixed Term Contract) Lazio

External Supply Operations Quality Manager (Fixed Term Contract)
Roma
Lazio, Lazio

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.

responsabilità

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).

esperienza

2 anni

competenze

Qualifications:

- Minimally BA/BS Science, Engineering, or related technical discipline with at least 7 years

in a GXP setting and/or Regulatory Affairs role

- At least 4 years of Product Quality Assurance experience in a GMP environment. Aseptic

manufacturing experience would be an asset.

- Advanced computer skills, MS Office and enterprise systems such as SAP, QTS, PDM,

Documentum platforms

- Command of English language required and multi-lingual is a benefit

- Strong verbal and written communication including presentation skills

- Shows strong negotiation skills and is diplomatic in communication with internal and

external customers

- Demonstrated ability to manage multiple projects and priorities

- Demonstrated ability to prioritize work, to act and work independently and to report

items as required to Team leader

- Demonstrated excellent organization skills

- Demonstrated experience managing complex quality and compliance activities in a

manufacturing plant or with a contractor

- Developing personal leadership to manage cross functional projects

- Developing ability to resolve conflicts

- Takes initiatives and is proactive, persistent

- Has a broad GMP and technical know-how to handle emerging issues

- Able to report remotely and deliver work independently

- Up to 20% travel may be required

A fixed-term position in administration is envisaged with classification according to the chemical collective bargaining agreement and classification commensurate with experience.

La ricerca è rivolta ai candidati ambosessi (L. 903/77). Ti preghiamo di leggere l'informativa sulla privacy Randstad (https://www.randstad. it/privacy/) ai sensi dell'art. 13 del Regolamento (UE) 2016/679 sulla protezione dei dati (GDPR).

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