External Supply Operations Quality Manager (fixed term contract) Settore: manifatturiero & produzioneCategoria: Tecnici specializzati, qualitàOrario di lavoro: GiornataContratto: SomministrazioneNumero posti: 1Luogo di lavoro: RomaRandstad 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 keycontractors for Pfizer and for assuring that the products supplied to our patients aremanufactured & tested in accordance with c-GMPs, the registration file and anyadditional country specific requirements.- This is highly independent position operating with minimal supervision, interacting withhigh 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 requirementswith contract manufacturers.
- ESOQ Manager will have significant interactions with many internal business andmanufacturing 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.ePDM) for changes initiated by or impacting ESOQ managed contractors.- Provide support for the closure of the deficiency letters, CMC Commitments, Regulatoryrequests for Renewals, New Product registrations and Post approval variations.- Main point of contact for Global Chemistry Manufacturing & Controls (GCMC) dpt orLocal Regulatory Affairs in Pfizer Country Offices (Single market prods) for the regulatoryactivities involving the ESOQ contractors.- As the Regulatory Expert, participate in Virtual Site Operating Teams (VSOT) or similarmeeting for ESOQ managed contractors and if needed, participate in Site Quality visits atthe contractors.- Support and Perform Lot Disposition for Biotech semi finished and finished products (ifapplicable).Requisiti: Qualifications:- Minimally BA/BS Science, Engineering, or related technical discipline with at least 7 yearsin a GXP setting and/or Regulatory Affairs role- At least 4 years of Product Quality Assurance experience in a GMP environment.
Asepticmanufacturing 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 andexternal customers- Demonstrated ability to manage multiple projects and priorities- Demonstrated ability to prioritize work, to act and work independently and to reportitems as required to Team leader- Demonstrated excellent organization skills- Demonstrated experience managing complex quality and compliance activities in amanufacturing 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).
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Riferimento: CX423877 Titolo di studio minimo: Comune e/o quartiere: Roma