Quality Compliance Sr. Specialist - maternity cover 12 months

at  Teva Pharmaceuticals

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Quality Compliance Sr. Specialist - maternity cover 12 months
Date: Oct 22, 2024
Location:Santhia, Italy, 0000
Company: Teva Pharmaceuticals
Job Id: 58895

WHO WE ARE

TAPI is the leading international supplier of active pharmaceutical ingredients (APIs). With the industry’s broadest portfolio including over 350 API products. We are the go-to global supplier for APIs, supporting 80% of top 50 global pharmaceutical companies. We are proud of our reliable history in the generic API industry dating back over 80 years, and the fact we are considered to be one of the most trusted API suppliers, these enable TAPI to lead the industry, based on our experience, expertise, technologies, and exceptional customer service.
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.

REQUIREMENTS

Education/experience:

• 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.

Skills:

• 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.

Languages:
Italian, good command of English is a strong preference.

In the Quality Compliance group we are looking for a brilliant profile reporting to the Quality Compliance Manager with the following responsibilities and activities:

• 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 cGMP 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.