Quality Senior Specialist

13 hours ago

Malanpur Madhya Pradesh, India TAPI Full time ₹ 6,00,000 - ₹ 12,00,000 per year

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
We're looking for a detail-driven Quality Senior Specialist with a strong foundation in GMP/GLP compliance and audit readiness.

What Are Your Responsibilities

  • Ensure on time dispatch related activity like verification of any deviation/OOS/LIR & other related QMS elements in the batch or in its batch train.
  • Ensure review of all documentation (i.e. batch records, test results, deviation, LIR, OOS, CAPA, validation, COA, Change Controls, etc.) and perform disposition (release/rejection) of batches.
  • Ensure review of executed document like batch record, analytical data, etc. and to ensure on time compliance of error/deviations identified (if any).
  • Monitoring and follow-up of corrective and preventive actions (review, approval, and on time closure of the CAPA) in order to resolve an event.
  • Review and approval Process/documentation (i.e. Protocol/report) of reviewing effectiveness to determine the effectiveness of a CAPA.
  • Involving in investigation, Review, and ensuring on time closure of the investigation with resolution including CAPAs along with effectiveness determination.
  • Responsible for assuring /coordinating for timely shipment, delivery, and/or receipt to assure compliance with regulatory requirements.
  • Responsible for preparation of Annual quality review/periodic quality review.
  • Any task assigned by QA manager.

Skills

  • Good understanding of Pharmaceutical Quality System, GMP & GLP.

Qualifications
The ideal candidate must have:

  • M.Sc. with 3-5 years of experience.

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

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