External Supply Operations Quality Manager

2 settimane fa

Lazio, Italia Buscojobs A tempo pieno

EXTERNAL SUPPLY OPERATIONS QUALITY MANAGER

Settore: manifatturiero & produzione

Categoria: Tecnici specializzati, qualità

Orario di lavoro: Giornata

Contratto: Somministrazione

Numero posti: 1

Luogo di lavoro: Roma

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 a 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 products) for the regulatory activities involving the ESOQ contractors.
  • As the Regulatory Expert, participate in Virtual Site Operating Teams (VSOT) or similar meetings 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).

Requisiti: 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, act and work independently, and 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 ambo (L.903 / 77). Ti preghiamo di leggere l'informativa sulla privacy Randstad ( ) ai sensi dell'art. 13 del Regolamento (UE) 2016 / 679 sulla protezione dei dati (GDPR).

Riferimento: CX423877

Titolo di studio minimo: Comune e / o quartiere: Roma

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