Quality Auditor, Randstad

Quality Auditor

Randstad

Location:

Italy, Rome

Category:

Finance

Contract Type:

Employment contract

Salary:

34000.00 - 40000.00 EUR / Year

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Job Description:

Randstad Inhouse Services, specialty Pharma, is looking for a resource on behalf of Pfizer srl to join the regulatory team as Contractor Regulatory Operations Associate. The position involves regulatory change management, renewal, and query activities for products manufactured by External Supply Quality managed contractors. Placement is expected at the Rome office with an initial fixed-term contract of 9 months.

Job Responsibility:

Initiate, review and approve regulatory changes through Pfizer enterprise system for changes initiated by or impacting ESOQ managed contractors
Provide support for the closure of deficiency letters, CMC Commitments, Regulatory requests for Renewals, New Product registrations, and Post approval variations
Act as the main point of contact for Global Chemistry Manufacturing & Controls (GCMC) department or Local Regulatory Affairs in Pfizer Country Offices for the regulatory activities involving the ESOQ contractors
Participate as the Regulatory Expert in Virtual Site Operating Teams (VSOT) or similar meetings for ESQ managed contractors
Participate in Site Quality visits at the contractors, if needed

Requirements:

Min. BA/BS in Science, Engineering, Pharmaceutical Sciences, Regulatory or related technical discipline
Min. 2 years of experience in GXP setting and/or Regulatory Affairs role (or 1 year with Master’s degree)
Good verbal & written skills
Advanced in computer skills such as MS Office applications and good knowledge of enterprise systems such as PDM, QTS Trackwise, Documentum platforms
Good command of English language and multi-lingual is a benefit
Strong verbal and written communication skills including presentation skills
Able to work in diverse multi-level, cross-divisional and multi-cultural working environment
Able to report remotely and deliver work independently
Show strong negotiation skills and customer focus
Is diplomatic in communication with internal and external customers

Nice to have:

Multi-lingual is a benefit
Advanced computer skills
Knowledge of enterprise systems such as PDM, QTS Trackwise, Documentum platforms

What we offer:

Position according to the chemical collective bargaining agreement commensurate with experience

Additional Information:

Job Posted:

April 07, 2025

Expiration:

April 25, 2025

Employment Type:

Fulltime

Work Type:

Hybrid work

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