QC Operation Laboratory Responsible - TAPI
Santhia, Italy, 0000
Who we are
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.
Our employees are at the core of our success. Our Headquartered is in Israel, TAPI employs more than 4,000 professionals at 14 sites worldwide. Our state-of-the-art production facilities are located in Italy, Hungary, the Czech Republic, Croatia, Israel, Mexico and India. Our significant ongoing investment in R&D generates a steady flow of APIs, enabling timely introduction of new products to market.
Main responsibilities and activities
In the QC Department we are looking for a brilliant profile reporting to the QC Manager with the following responsibilities and activities:
- Use the StarLims in order to perform all the approval activities related to system management; in particular: tests approval, monographs approval, clients approval, stability protocols/studies approval, analytical sheets approval.
- Use the TrackWise system in order to manage/approve the laboratory investigations/deviations.
- Use the TrackWise system in order to manage/approve the CCM records.
- Act as QC manager backup in TrackWise, Smarteam and LIMS systems.
- Manages the practical activities of the department in order to ensure compliance with xGMPs, regulatory guidelines / Divisional Policy etc.
- Collaborates with the department manager in the issuance of analytical control procedures following reclamation activities.
- Supports the department manager during audits and inspections (internal and external).
- Ensures compliance with safety regulations in the department.
Coordinate a group of supervisor and lab analysts:
- Supports Supervisors and, if necessary, Laboratory Analysts, in laboratory investigations (LIR, OOS, complaints) and in the implementation of effective CAPAs.
- Supports the Supervisors in planning the activities of the department.
- If necessary, replaces the Supervisor in the review and approval of the analytical work.
- Review and approve the laboratory activities necessary for its maintenance (eg, instrumental requalification, periodic checks, daily calibrations).
- Represents the practical contact point for the other departments of the Site.
- Collaborates in the organization of internal professional refresher courses.
- In line with the policies of the Human Resources department, it ensures the motivation and development of employees, intervening with appropriate managerial actions where necessary.
Requirements
Education:
University degree in Chemistry, Pharmacy or CTF
Skills:
- Ability to work cross-functionally
- Familiar with Quality IT Systems
- Experience in Inspection management
Languages:
English and Italian (level of proficiency)
Minimum Experience / Training required:
Minimum: 4 years work experience in Quality Control
What we offer?
We try to take care of our employees, offering them small and large benefits. By way of example:
- Canteen
- Working flexibility for Caregivers and parents
- Coffee Key
- Recognition Program
- Welfare Platform
- Health agreement with medical centers of excellence
- Highly inclusive and multicultural working environment
- Continuous learning and development programs (with full access to Linkedin Learning!)
Type of contract: long term contract
Location and working program
Santhià (VC), 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.