Teva Quality Control Manager 

Italy, Lombardy 

907030590

In the Quality Department we are looking for a brilliant profile reporting to Site Quality Head with the following responsibilities and activities:

• Ensure that the organization of the quality Control is fully in compliance with current GMP, GLP, Data Integrity requirements.
• Ensure adherence to environment, health and safety company requirements as well as legal obligations for his department.
• Behave according to company Ethical Code and company values.
• Manage, plan and monitor the activities of all Quality Control areas: chemical Laboratory, in process controls and packaging materials laboratory.
• Ensure that, within the QC control activities, the technical dossiers of the products and/or the monographs of the Pharmacopoeias correspond to the related methods of analysis and specifications. Ensure the execution of all required analysis/verifications.
• Ensure that all methods applied by Quality Control are validated according to the current regulations.
• To guarantee the execution of the stability programs in compliance with the regulations in force.
• Guarantee the accuracy and consistency of the evaluations given in the certifications issued by the quality control function before submitting the same certifications to the final evaluation of the Qualified Person.
• Verify and approve for cGMP compliance all documentation issued by Quality Control including instructions (e.g. sampling), specifications and methods.
• Verify and approve the LIR/OOS reports issued by Quality Control.
• Guarantee to the functions of the site the necessary analytical support and/or relevance of the activities/ responsibility for the role (e.g.: technology transfer, change control, deviations, APR, etc...).
• Constantly monitor the efficiency and quality status and performance of quality control through a continuous measurement and evaluation of indicators of performance (KPI). Ensure the application of specific preventive/improvement actions, promoting their implementation.
• Issue periodic quality reports in order to summarize and monitor the processes trend, the environments, the staff and, in general, the performance of the site from the point of view of quality, both in order to continuously improve the Site Quality System.
• Guarantee the compliance to the Data Integrity requirements for the laboratory activities.
• Assist the Qualified Person and collaborate with them in the performance of their functions (DL.219/06 art. 52, paragraph 10 and art. 64, paragraph 3 and subsequent update of Legislative Decree no. 17 of 19 February 2014).
• Manage and monitor the budget of quality control department, including staff budgets, equipment, materials. Proposing investment and define the needs of the department.
• Continuously update the activities carried out by quality control department as per national and international laws and guidelines for the activities of competence.
• Ensure the drafting and revision as per relative timelines of the SOPs and training execution into QC department.
• Ensure the correct maintenance and archive of all GMP documentation issued by Quality Control department.
• Define the training and training plan of the quality control personnel.
• Ensure the succession plan within the QC function.

Education:

• University degree in accordance with legal requirements.
• Preferred: University degree in Chemistry, Pharmacy, CTF or Biology.

Skills:

• Ability to work cross-functionally
• Strong Change Management capabilities
• Strong Project Management
• Familiar with Quality IT Systems: i.e. TrackWise
• Experience in Inspection management

English and Italian (level of proficiency)

Minimum Experience / Training required:

Minimum: 5 years work experience in Quality Control or related field experience is required and relevant and verified Training/Certification for the role is mandatory.

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

• Ticket Restaurants for each working day, smartworking days included
• Working flexibility for Caregivers and parents
• Recognition Program
• Welfare Platform
• Highly inclusive and multicultural working environment
• Flexible working environment (2 days home office per week)
• Continuous learning and development programs (with full access to Linkedin Learning!)

Type of contract: long term contract

Villanterio (PV) from Monday to Friday.