Quality Operational Manager & QP

Are you ready to join a growing, global drug development and manufacturing organization that puts people first?  Come to Adare!  We work closely with our pharmaceutical industry partners during all phases of drug development and commercial manufacturing with a mission of improving the lives of patients and medicines essential to people all over the world.  Every role within Adare offers you a unique, customized experience with a chance to make a real impact that is critical to our success.  With the help of people like you dedicated to our mission, Adare is transforming lives by transforming drug delivery!

Join our mission at Adare!

What can Adare offer you?


* Health Insurance


* Pension Plan


* Benefits as per internal agreement


* Career growth and internal opportunities


* Performance/production bonus


* Employee Recognition Programs.

 

We are seeking to hire a Manager, Quality Assurance Operations & QP  to join our Italian QUALITY TEAM at Pessano con Bornago.

If any of the below describes you, we would love to meet you! 

 

Job Summary

The Manager, Quality Assurance Ops acts as lead for the QA Operation group and carries out and covers the following responsibilities:


* Manages the QA Specialist/Sr Specialist group of the site for the deviation/ investigation , Batch Record reviews  and release functions and ensures their correct training and professional growth


* Manages the QA Specialist/Sr Specialist quality on the floor of the site for the oversight of production activities


* Is the first point of contact with customer relating deviation, CAPA and complaints


* Acts as a Qualified Person at Pessano site


* Supervise and verify that each batch of medicine is produced and controlled by preparing all the necessary operations and measures to allow the aforementioned controls to be carried out


* Is responsible for managing the documentation relating to the production and controls of the products and its availability


* Ensure the management of narcotic and psychotropic substances and drug precursors


* Identifies areas and activities for improvement from a procedural point of view, promotes the drafting of the Standard Operating Procedures and their approval and application


* Manages the personnel who deal with the deviations and non-conformities found, ensuring the quality of the outgoing product and verifying the effectiveness of the corrective actions taken


* Manages the personnel who deal with customer complaints with related investigation, corrective activities, response and closure of complaints


* Works cooperatively with managers, supervisors, collaborators, customers and the public


* Complies with the policies, procedures and regulations in force in the company.

Required Skills and Qualifications


* Master's Degree in Scientific Disciplines: Chemistry and Pharmaceutical Technology (CTF ), Biological Sciences , Pharmacy or similar
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