Quality Compliance Sr. Specialist - maternity cover 12 months

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.

Main responsibilities and activities

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.

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.

What we offer?

We try to take care of our employees, offering them small and large benefits. By way of example:

• 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!)

Type of contract: maternity cover - 12 months

Location and working program

Santhià (VC), from Monday to Friday

Teva's commitment to equal opportunities

Teva is committed to equal opportunities in the world of work. Our global policy requires equal employment opportunities to be provided regardless of age, race, religion, health, identity, gender expression, protected categories or any other legally recognized status that is entitled to protection under applicable laws.