Quality Compliance Sr. Specialist - maternity cover 12 months Date: Oct 22, 2024
Location: Santhia, Italy, 0000
Job Id: 58895
TAPI is the leading international supplier of active pharmaceutical ingredients (APIs). With the industry's broadest portfolio including over 350 API products, we support 80% of top 50 global pharmaceutical companies. We have a reliable history in the generic API industry dating back over 80 years, and we are considered one of the most trusted API suppliers. Our experience, expertise, technologies, and exceptional customer service enable TAPI to lead the industry.
Our employees are at the core of our success. TAPI employs more than 4,000 professionals at 14 sites worldwide, with state-of-the-art production facilities located in Italy, Hungary, the Czech Republic, Croatia, Israel, Mexico, and India.
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 tools. Inspection Readiness – support the team in preparing the Site to be ready for an Authority Inspection. Regulatory Inspections – regulatory inspections preparation, execution, and CAPA plan drafting. Execute and report Internal Audits and Quality Walk Around to guarantee site compliance to cGMP standards. Customer audit - preparation, execution, and CAPA plan drafting. Supplier – management of suppliers according to the internal procedure. Perform Investigations, CAPA & Deviation Review / Change Control - apply a structured methodology to investigation, change documentation. Track and report 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 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 to interact with employees, other managers, and cross-functional peers. Ability to work cross-functionally. Languages:
Italian, good command of English is a strong preference.
What we offer? We take care of our employees, offering them various benefits, including:
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.
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