Compliance CoordinatorApply Now Email Me Job ID SR0032721 Date posted 02/04/2019 Location:Rufina, Italy
A. Compliance Documentation
Act as tracking coordinator for Rieti Plant collecting, archiving and distributing License Information (LI) and Post market Commitments (PMC) up to the implementation of needed actions.
Assure the preparation of documentation (such as GMP certificate and Manufacturing License) requested for Variations/Submission/Site Accreditation in foreign countries.
Support the revision of Site Master File.
B. Project related Activities
Support the preparation and the revision of documents related to Rieti Projects such as Risk Assessment, SOPs and Technical Document.
Support the drafting of Common Technical Document _ Module 3 (Quality) sections (3.2.S, 3.2.P, 3.2.A) as per company plans and needs.
Support the activities tracking as per project needs
C. Regulatory Inspection, Corporate Audit, Inspection Readiness Assessment
Support regular GMP or Pre-Approval Inspections conducted by Authorities or Audits by third parts as needed. Support Internal audit (Corporate/IRA) as needed.
Education & Experience Requirements
Essential: Degree in Chemistry / Biochemistry / Biology or equivalent scientific disciplines. Good written and spoken English language.
Desired: 1- 3- years of experience in Pharmaceutical Quality System and cGMP. Experience on Project management and/or Project management software/tools. Communication and relationship skills. Team work oriented.
Notice to Employment / Recruitment Agents:
Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.