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).
livello di studio
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