Italy Job Openings
Teva Pharmaceuticals
Quality Compliance Sr. Specialist - maternity cover 12 months
Santhià
October 22, 2024
Our employees are at the core of our success. Our Headquartered is in Israel, TAPI employs more than 4,000 professionals at 14 sites worldwide. Our state-of-the-art production facilities are located in Italy, Hungary, the Czech Republic, Croatia, Israel, Mexico and India. Our significant ongoing investment in R&D generates a steady flow of APIs, enabling timely introduction of new products to market.
- Perform Risk Assessment/Gap assessment using various tool.
- Inspection Readiness – support the team in preparing the Site to be ready to an Authority Inspection.
- Regulatory Inspections –regulatory inspections preparation, execution and CAPA plan drafting.
- Executes and reports Internal Audits and Quality Walk Around, in order to guarantee site compliance to c GMP standards.
- Customer audit - preparation, execution and CAPA plan drafting.
- Supplier – management of supplier according to the internal procedure.
- Perform Investigations, CAPA & Deviation Review / Change Control - Applies a structured methodology to investigation, change documentation. Tracks and reports on status.
- Site Master File - Drafting and maintenance of a Site Master File (SMF).
- Training – Perform GMP training to site personnel and support the compliance team in the new training initiatives.
- Quality Council- preparation of Site Quality Council.
- Bachelor’s degree in Chemistry, Pharmacy, Life Sciences or closely related discipline is required.
- At least 3 years of work experience in Quality Assurance (quality compliance or system is preferred).
- Strong experience in drafting risk assessments using various tools (e.g. FMEA, etc.).
- Strong experience in QMS (DR, CAPA, Change Control).
- Experience in audit management (both internal audit and external from customer and/or from Regulatory Authority).
- Experience in Data Integrity application on Computer System is preferred.
- Able to work with a high level of autonomy.
- Able in the interaction with employees, other manager and cross-functional peers.
- Ability to work cross-functionally.
Italian, good command of English is a strong preference.
- Canteen
- Working flexibility for Caregivers and parents
- Coffee Key
- Recognition Program
- Welfare Platform
- Health agreement with medical centers of excellence
- Flexible working environment (2 days home office per week)
- Highly inclusive and multicultural working environment
- Continuous learning and development programs (with full access to Linkedin Learning!)
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