Quality Compliance Sr. Specialist

1 settimana fa


Montà, Italia Tevapharm A tempo pieno

Quality Compliance Sr. Specialist - maternity cover 12 monthsDate: 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 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. Our employees are at the core of our success. TAPI employs more than 4,000 professionals at 14 sites worldwide, with significant ongoing investment in R&D generating a steady flow of APIs.
Main responsibilities and activitiesIn 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 for Authority Inspection.Regulatory Inspections – preparation, execution, and CAPA plan drafting.Execute and report Internal Audits and Quality Walk Around to ensure site compliance with cGMP standards.Customer audit - preparation, execution, and CAPA plan drafting.Supplier management according to internal procedures.Perform Investigations, CAPA & Deviation Review / Change Control - applies a structured methodology to investigation, tracks and reports on status.Draft and maintain a Site Master File (SMF).Perform GMP training for site personnel and support compliance team in new training initiatives.Preparation of Site Quality Council.RequirementsEducation/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 preferred).Strong experience in drafting risk assessments using various tools (e.g., FMEA).Strong experience in QMS (DR, CAPA, Change Control).Experience in audit management (both internal and external).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 benefits such as:
CanteenWorking flexibility for caregivers and parentsCoffee KeyRecognition ProgramWelfare PlatformHealth agreement with medical centers of excellenceFlexible working environment (2 days home office per week)Highly inclusive and multicultural working environmentContinuous learning and development programs (with full access to LinkedIn Learning)Type of contract: maternity cover - 12 months
Location and working programSanthià (VC), from Monday to Friday
Teva's commitment to equal opportunitiesTeva is committed to equal opportunities in the workplace. Our global policy requires equal employment opportunities to be provided regardless of age, race, religion, health, identity, gender expression, or any other legally recognized status entitled to protection under applicable laws.

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