Quality Senior Specialist (QMS)

At TAPI, were not just a company—were a community committed to advancing health from the core. As the worlds 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, were 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.

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.
  

Qualification : Msc- Chemistry

Experience Required: 5-6 Years in Pharma API

Make Your Mark with TAPI

Your journey with TAPI is more than a job—its an opportunity to make a lasting impact on global health. If youre ready to lead, innovate, and inspire, were excited to welcome you to our team. Together, lets 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.