Job Description

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.

Key Responsibilities: * Responsible for processing and oversight of changes through the generation, justification, impact assessment, modification, review, approval, and implementation workflow. This includes but is not limited to SOPs, production records, test methods, specifications, protocols, reports, equipment, processes, material suppliers, facilities, computer systems etc.

• Responsible for processing of documents through the generation, modification, review, and approval workflow. This includes but is not limited to SOPs, production records, test methods, protocols, reports, labeling, etc. also, archival of records.
• Responsible for review/approval of all documentation associated with the establishment and configuration of GMP equipment including laboratory equipment. This includes any Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) documents.
• Responsible for tracking, trending, and reporting of quality metrics for site, regional, and global review. Trending as required by SOP, Corp. Standards, and/or regulations.
• Responsible for review/approval of all documentation associated with the establishment and configuration of a GMP computerized system. This includes all lifecycle documents.
• Responsible for Review of regulatory and quality compliance requirements and global procedures, performance of gap assessments, and establishment or improvement of SOPs covering all areas of applicability. Development and monitoring of corrective action plans where needed.
• Ensuring quality support to regulatory affairs as it relates to updates/changes to market authorizations.
• Review of all documentation (i.e. LIR, OOS, Change Controls, etc.).
• Ensuring and performing investigation into a product quality complaint with resolution including corrective and preventive actions and closure of the investigation.
• Ensure review, approval, and on time closure of the laboratory investigation / events with resolution including corrective and preventive actions along with effectiveness determination.
• Ensuring quality oversight of maintenance and calibration activities including facilities and equipment and any critical systems such as process water etc.
• Responsible for management of regulatory authority and other external compliance audits (e.g. Customer audits) including communication, tracking and resolution of observations. Management of communications with regulatory agencies including required reporting and resolution of any actions required by the agencies.

Qualifications
The ideal candidate will have:
Education: M.Sc. in Chemistry or B.Tech/BE (Chemical Engineering) or B.Pharma
Experience: Minimum 10 years of experience in a regulated pharmaceutical environment.
Preferred Industries: API / Pharma.
Additional 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!

Skills Required