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…
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…
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…
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…
Cég leírása A TAPI-nál nemcsak egy vállalat vagyunk, hanem egy közösség is, amely elkötelezett az egészség fejlesztése iránt. A világ vezető gyógyszerhatóanyag-gyártójaként a világ 50 legnagyobb gyógyszeripari vállalatán…
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…
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…
Skills: Project Management, Salesforce Administration, Business Systems Management, Risk Mitigation, KPI Development
Gyógyszerhatóanyaggyártási Folyamat- és Technológiai szakértő
Debrecen, North Great Plain, Hungary · On-site
Mid level
Cég leírása A TAPI-nál nemcsak egy vállalat vagyunk, hanem egy közösség is, amely elkötelezett az egészség fejlesztése iránt. A világ vezető gyógyszerhatóanyag-gyártójaként a világ 50 legnagyobb gyógyszeripari vállalatán…
Skills: Process Optimization, Technology Transfer, Statistical Tools, CPV (Continuous Process Verification), Experimental Design
Cég leírása A TAPI-nál nemcsak egy vállalat vagyunk, hanem egy közösség is, amely elkötelezett az egészség fejlesztése iránt. A világ vezető gyógyszerhatóanyag-gyártójaként a világ 50 legnagyobb gyógyszeripari vállalatán…
Skills: Occupational Health and Safety, Risk Assessment, Environmental Protection, Fire Safety, Production Scheduling
Cég leírása A TAPI-nál nemcsak egy vállalat vagyunk, hanem egy közösség is, amely elkötelezett az egészség fejlesztése iránt. A világ vezető gyógyszerhatóanyag-gyártójaként a világ 50 legnagyobb gyógyszeripari vállalatán…
Skills: Production Planning, Personnel Management, Performance Monitoring, KPI Tracking, Documentation
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…
Skills: Batch Manufacturing, Process Optimization, Team Leadership, GMP Compliance, Production Planning
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…
Skills: Mechanical Engineering, Preventive Maintenance, cGMP Compliance, Team Coordination, Problem Solving
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…
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…
Skills: Business Development, Key Account Management, API Sales, Negotiation, Stakeholder Management
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…
Skills: Business Development, Key Account Management, API Sales, Negotiation, Stakeholder Management
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…
Skills: Business Development, Key Account Management, API Sales, Negotiation, Stakeholder Management
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…
Skills: Business Development, Key Account Management, API Sales, Contract Negotiation, Market Analysis
Cég leírása A TAPI-nál nemcsak egy vállalat vagyunk, hanem egy közösség is, amely elkötelezett az egészség fejlesztése iránt. A világ vezető gyógyszerhatóanyag-gyártójaként a világ 50 legnagyobb gyógyszeripari vállalatán…
Skills: Fermentation Media Preparation, Raw Material Handling, Equipment Sterilization, Documentation, Microsoft Excel
Cég leírása A TAPI-nál nemcsak egy vállalat vagyunk, hanem egy közösség is, amely elkötelezett az egészség fejlesztése iránt. A világ vezető gyógyszerhatóanyag-gyártójaként a világ 50 legnagyobb gyógyszeripari vállalatán…
Skills: Chemical Process Operation, Computerized Process Control Systems, Documentation Management, Equipment Maintenance, Safety Protocol Compliance
Cég leírása A TAPI-nál nemcsak egy vállalat vagyunk, hanem egy közösség is, amely elkötelezett az egészség fejlesztése iránt. A világ vezető gyógyszerhatóanyag-gyártójaként a világ 50 legnagyobb gyógyszeripari vállalatán…
Skills: Energy Network Operation, Cooling Tower Maintenance, Heating System Troubleshooting, Boiler Operation, Turbine Operation
Sign up with Clera and we'll reach out the moment a role actually fits you — no more spraying applications into the void.
Full-time
postgraduate degree
Posted 18h ago
~40 hrs/week
Responsibilities
The role ensures Quality Systems compliance with GMP and regulatory requirements through the management of validation, change control, and documentation. It provides quality oversight to manufacturing and laboratory functions to maintain product quality and data integrity.
Requirements
The candidate must hold a Master of Science degree in Chemistry. A minimum of 5-6 years of experience in the pharmaceutical API industry is required.
Full 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.
Job Description
Purpose of the Job
To ensure compliance of Quality Systems with GMP, regulatory, and corporate requirements through effective management of validation, change control, documentation, qualification, training, quality metrics, audits, and continuous improvement activities. The role provides quality oversight and support to manufacturing, laboratory, engineering, and regulatory functions to maintain product quality, data integrity, and regulatory compliance in an API manufacturing environment.
Key Responsibilities
Data Management & Analysis: Collect, compile, analyze, and review data related to manufacturing, testing, sourcing, deviations, stability studies, and change controls to support and maintain the validated status of products.
Batch Documentation Control: Manage and ensure the controlled issuance of Batch Manufacturing Records (BMRs) and related documentation, including assignment of batch numbers and issuance to operations for execution.
Change Control Management: Oversee the Change Control process, including initiation, impact assessment, review, approval, implementation, and closure of changes related to GMP systems and operations.
Validation & Qualification Oversight: Review and approve validation protocols, reports, and qualification documentation associated with GMP equipment, laboratory instruments, processes, cleaning activities, and computerized systems
GMP Documentation Management: Manage GMP documentation through generation, revision, review, approval, issuance, control, and archival processes, including the Validation Master Plan (VMP).
Quality Metrics & Reporting: Track, trend, analyze, and report Quality Metrics for site management reviews and continuous improvement initiatives.
Compliance & Continuous Improvement: Perform regulatory and quality compliance assessments, gap analyses, SOP development, and monitoring of CAPA effectiveness.
Regulatory Support: Provide Quality Systems support to Regulatory Affairs regarding regulatory submissions, market authorizations, and post-approval changes.
Training & Audit Programs: Manage GMP training programs, personnel qualification activities, Quality Gemba Walks, self-inspections, and internal audits as per approved procedures.
Computerized Systems Compliance: Review and approve lifecycle documentation associated with GMP computerized systems and ensure data integrity compliance.
Qualifications
Qualification : Msc- Chemistry
Experience Required: 5-6 Years in Pharma API
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!
Our Commitment
At TAPI, we believe great talent comes from many backgrounds and experiences. As an equal opportunity employer, we are committed to building a diverse, inclusive, and supportive workplace where everyone can belong, contribute, and grow. We encourage applications from all individuals who share our curiosity, ambition, and values.
Since our founding in 1935, TAPI has been at the forefront of advancing health through innovation and dedication. Today we continue to build on this strong legacy, driving progress in the pharmaceutical industry. Our commitment to health is unwavering, from developing high-quality generics to pioneering cutting-edge solutions.
With our longstanding experience and worldclass experts, we provide one of the industry's most comprehensive API portfolios. We also offer customized CDMO services, utilizing our expertise in a wide range of technologies to meet the diverse needs of our partners, ensuring flexibility and excellence in every project.
Every ingredient we create contributes to a healthier life, and every customer we supply fulfills their mission to cure. Join us in our journey to improve global health, one ingredient at a time.
Offices: 124 Devorah Haneviaa St., Tel Aviv, 6944020, IL · 400 Chestnut Ridge Road, Woodcliff Lake, New Jersey 07677, US · Piet Heinkade 107 (Piet Hein Building), Amsterdam, 1019 GM, NL · Teva Pharmaceutical & Chemical Industries India Pvt. Ltd., 601, Omega, Hiranandani Gardens, Main Street Powai,, Mumbai, 400 076, IN · Jianguoroad No.91, No. 803-807,8F, Gemdale Plaza Block B, Beijing, CN
Active Pharmaceutical IngredientsAPIand CDMOChemicalHealth CareMedical DeviceManufacturingPharmaceutical
Since our founding in 1935, TAPI has been at the forefront of advancing health through innovation and dedication. Today we continue to build on this strong legacy, driving progress in the pharmaceutical industry. Our commitment to health is unwavering, from developing high-quality generics to pioneering cutting-edge solutions.
With our longstanding experience and worldclass experts, we provide one of the industry's most comprehensive API portfolios. We also offer customized CDMO services, utilizing our expertise in a wide range of technologies to meet the diverse needs of our partners, ensuring flexibility and excellence in every project.
Every ingredient we create contributes to a healthier life, and every customer we supply fulfills their mission to cure. Join us in our journey to improve global health, one ingredient at a time.
Offices: 124 Devorah Haneviaa St., Tel Aviv, 6944020, IL · 400 Chestnut Ridge Road, Woodcliff Lake, New Jersey 07677, US · Piet Heinkade 107 (Piet Hein Building), Amsterdam, 1019 GM, NL · Teva Pharmaceutical & Chemical Industries India Pvt. Ltd., 601, Omega, Hiranandani Gardens, Main Street Powai,, Mumbai, 400 076, IN · Jianguoroad No.91, No. 803-807,8F, Gemdale Plaza Block B, Beijing, CN
Active Pharmaceutical IngredientsAPIand CDMOChemicalHealth CareMedical DeviceManufacturingPharmaceutical