Quality Assurance Specialist

Quality Assurance Specialist

for the site Carugate MI, Italy

Would you like to make a valuable contribution to the health of patients? And do something really meaningful on your own responsibility? Then we look forward to hearing from you! Excellence beyond manufacturing - that's what we stand for as Aenova, one of the world's leading contract manufacturers and developers for the pharmaceutical industry with 4,000 employees at 15 sites. Our site in Carugate is a competence center for semisolids, these include creams and gels.

Your key responsibilities

• Ensure that the products have the required quality characteristics.
• Ensure compliance with company quality standards required by current regulations (European and international GMP standards).
• Ensure compliance with company quality standards required by customers.
• Support the relevant business functions in ensuring an effective change control system by coordinating a cross-functional risk evaluations of proposed changes in order to define appropriate action plans and implementation dates; maintaining an up-to-date status report on the progress of all changes to ensure timely interventions for their implementation.
• Support the business functions in the management of deviations, by coordinating a timely multi-disciplinary investigation conduction to immediately intercept issues and avoid impact extension; by the assessment of effective root causes and related CAPAs.

Your profile

• Degree in scientific disciplines.
• Knowledge of European and international GMP standards.
• Knowledge of regulations applied to the production of pharmaceutical products (semi-solid and/or liquid is a plus).
• Proficiency in English, spoken and written.

Your motivation

Are you looking for new challenges in a highly competitive environment? And you want to tackle them creativelyand on your own responsibility? Do you prefer a "get-it-done" culture and think in terms of solutions ratherthan problems? What are you waiting for? We would be happy to explain our corporate benefits in a personalconversation!

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