- Scientific degree
- Experience in Pharmaceutical Industries
- Experience in Quality Compliance
- Good English, both written and spoken
- Teamwork
- Good communications skills
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1 giorno fa
Takeda Pisa, Italia A tempo pienoDescription · Job Title: Changes Specialist · Location: Pisa · As a Changes Specialist you will oversee the management of all activities related to production documentation ownership, including revision, issuance, and maintenance of documentation according to GDDP rules, ensur ...
Global Quality Compliance Specialist - Castelvecchio Pascoli, Italia - Adhr
Descrizione
LA SPECIALIZZAZIONE HEALTHCARE & PHARMA DI ADHR GROUP, RICERCA PER IMPORTANTE AZIENDA FARMACEUTICA:
Global Quality Compliance Specialist
the candidate will report to Global Compliance Manager and she/he will carry out the following activities:
• Collaborate with the direct manager on the lifecycle and the development of the Company Document System (Policies, SOPs Global).
• Manage Global documentation training.
• Draft and periodically review the Quality Agreements with third parties (CMOs and Distributors).
• Periodically prepare report relating to the Global Quality KPIs
• Handle Global Change Requests.
• Collaborate with the direct manager in issuing the yearly Global Supplier Audits Program
• As a compliance expert, participate in Global projects in collaboration with the direct manager.
• Collaborate with the direct manager in reviewing the data and trends relating to the activities carried out at the production site level and in promoting standardization and continuous improvement, by sharing best practices and lessons learned.
• Act as Lead Auditor for self audit activities and third party audits.
• Periodically check the performance level of suppliers and distributors.
• Collaborate with direct manager and the personnel of the production plants on the actions to be implemented following receipt of reports/complaints from the market.
• Provide support together with the direct manager to production sites for the resolution of deviations that emerged during the inspection phase and regulatory deficiencies.
• Collaborate with the other corporate functions to ensure continuous improvement of the Quality System, with particular focus on GMP and ISO systems.
• Together with the direct manager, collaborate with the subsidiaries in improving their respective quality systems by promoting their integration into the Kedrion System.
• From a qualitative point of view, collaborate with the direct manager to the distribution in Italy of medical devices supplied by third parties.
• Keep him/herself updated on the Regulations and guidelines issued by regulatory bodies and GMP organizations in the relevant sector, ensuring the implementation of any updates on Policies and procedures at a Global level.
Requirements:
Location: Castelvecchio Pascoli, Barga (LU) or S. Antimo (NA)
Le ricerche sono rivolte a candidati dell'uno e dell'altro sesso ai sensi delle L.903/77 e L.125/91. I candidati sono invitati a leggere l'informativa privacy sul sito di Adhr Group ai sensi dell'art. 13 del Regolamento (UE) 2016/679 sulla protezione dei dati (GDPR). ADHR GROUP – Agenzia per il lavoro S.p.a. Iscr. Albo Agenzie per il Lavoro Sez. I – Aut. Min. prot.n.13/I/
