Production Specialist (Documents Specialist)

Company Description

At TAPI, we’re not just a company—we’re a community committed to advancing health from the core. As the world’s leading supplier of active pharmaceutical ingredients (APIs), we 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, as well as custom CDMO services, we’re shaping the future of health worldwide.Our strength lies in our people—a team of over 4,200 professionals across 13 state-of-the-art facilities in Italy, Hungary, the Czech Republic, Croatia, Israel, Mexico, and India. Together, we innovate, solve problems, and deliver excellence. Join us and be part of a mission that transforms lives.

Main Responsibilities:

• Responsible for the validation protocol/report preparation and approval from QA.
• Responsible for follow up and tracking of Validation.
• Responsible for the study protocols/reports preparation and approval from QA.
• Responsibility for preparation of cleaning matrix/protocols/reports.
• Responsible for preparation of investigation report.
• Responsible for reviewing the investigation report by QA person.
• Responsible for closer of investigation in track-wise on time.
• Preparation of manufacturing process batch card through the R&D/Pilot report.
• Preparation of different type of cleaning batch cards e.g. Product change over cleaning, periodic cleaning, general cleaning etc.
• Initiation of change controls in Track wise for manufacturing process/product change over cleaning batch cards.
• Responsible for uploading of manufacturing/Cleaning batch cards in Smart Team.
• Responsible for coordinate with dispatch person for smooth dispatch.
• Responsible for change/correction/preparedness and initiation of SOP change control.
• Responsible for tracking/follow up of process/cleaning validation protocols/reports and SOP.
  

Qualifications

Educational Qualification:

Bachelor/Master of science (Chemistry) / Diploma (Chemical Engineering)

Experience

Minimum 5 YearsAdditional Information

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. Together, let’s shape the future of pharmaceuticals. Apply on top of this page and our talent acquisition team will be in touch soon!