TAPI is the leading international supplier of active pharmaceutical ingredients (APIs). With the industry's broadest portfolio including over 350 API products. We are the go-to global supplier for APIs, supporting 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, these enable TAPI to lead the industry, based on our experience, expertise, technologies, and exceptional customer service.
Main 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.
Requirements 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
Languages: 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.
What we offer? 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
Location and working program Villanterio (PV) 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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