Quality Assurance Specialist - Villanterio (PV)

Overview

At TAPI, we’re a community committed to advancing health from the core. We are the world’s leading supplier of active pharmaceutical ingredients (APIs) and partner with 80% of the top 50 global pharmaceutical companies. With a legacy spanning over 80 years and a portfolio of more than 350 products, we also offer custom CDMO services across 13 state-of-the-art facilities in Italy, Hungary, the Czech Republic, Croatia, Israel, Mexico, and India. Our strength lies in our people—a team of over 4,200 professionals who innovate, solve problems, and deliver excellence.

Job Description
Reporting to the QA Manager within the Quality team, the role ensures batch compliance to establish a disposition decision of release or rejection, including quality oversight and monitoring on the shopfloor.

Responsibilities

• Interacts effectively with employees; managers and cross-functional peers. May represent QA team on cross-functional project teams.
• Performs quality documentation activities: issuance of GMP documentation and logbooks, updates to the SOP archive.
• Performs batch documentation review prior to batch release and packaging records review prior to shipment to evaluate compliance with internal procedures.
• Ensures the process of observing, reviewing, and auditing production operations to facilitate batch review and assure compliance.
• Maintains quality oversight and monitoring at shopfloor, participating in Quality Walk Around plans in production areas.
• Supports, reviews and approves investigations into events including corrective and preventive actions, ensuring on-time closure.
• Collaborates with the Quality Assurance Manager on reviewing the effectiveness of corrective or preventive actions.
• Issues the Annual Product Reviews, verifying the data collected.
• Collaborates with QP, Quality Assurance Manager and Compliance to oversee changes through the generation, justification, impact assessment, modification, review, approval, and implementation workflow (including SOPs, production batch and cleaning records, protocols, reports, equipment, processes, material suppliers, facilities, computer systems, etc.).
• Collaborates with QP and Quality Assurance Manager in Complaint Management.
• Participates in the review/approval of documentation related to the validation of cleaning procedures for equipment trains and related verifications, and documentation for manufacturing procedures/master batch cards to ensure compliance.
• Participates in regulatory authority and external compliance audits; supports Inspection Readiness Plan execution.
• Under ethical guidelines, collaborates with Qualified Persons and Regulatory Affairs to ensure conformity and completeness of regulatory documentation.
• Supports archiving of training documentation and periodic review of annual training programs.
• Uses and manages electronic systems used in the Quality Department.

Qualifications

Education:

• Bachelor’s degree or Master degree in Chemistry, Pharmacy, Life Sciences or closely related discipline is required.

Skills:

• Able to work with autonomy with supervision where necessary.
• Ability to work cross-functionally.
• Familiar with Quality IT Systems, e.g., TrackWise.

Languages: Italian, good command of English is a strong preference.

Minimum Experience / Training Required:
At least two years of work experience in Quality or related field is required. Preferred experience in the API industry.

Benefits

• Ticket restaurant
• Recognition Program
• Welfare Platform
• Coffee token
• Health insurance with access to top medical centers
• Inclusive and multicultural work environment
• Ongoing learning and professional development programs

Equal Opportunities

TAPI is committed to ensuring equal opportunities in the workplace. Our global policy provides that employment opportunities are offered regardless of age, race, religion, health status, identity, gender expression, protected categories, or any other legally recognized status entitled to protection under applicable laws.

Make Your Mark with TAPI

Your journey with TAPI is more than a job—it’s an opportunity to make a lasting impact on global health. If you’re ready to lead, innovate, and inspire, we’re excited to welcome you to our team. Apply on top of this page and our talent acquisition team will be in touch soon!