Quality Control Analyst (HPLC)

Posted 2 Days Ago
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Malanpur, Bhind, Madhya Pradesh, IND
In-Office
Expert/Leader
Pharmaceutical • Chemical • Manufacturing
The Role
Perform HPLC and other analytical testing per monographs/SOPs, manage sampling and LIMS data entry, support audits and QMS activities, investigate OOS/OOT/LIR, maintain instrument calibration, sample storage, safety, data integrity, and drive QC efficiency and documentation.
Summary Generated by Built In
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 Control Analyst (HPLC) with a strong foundation in GMP/GLP compliance, QMS Activities and Audit readiness.

Main Responsibilities:

  1. Sampling, analysis/ planning of RM/FG/Intermediates/Water/Environment monitoring samples based on requirement and result entry in analytical sheets, QA form and LIMS.
  2. Perform analytical test according to the monograph and SOP based on requirement.
  3. 24 x 7 audit readiness.
  4. Participation in internal, external, regulatory audits.
  5. Ensure 100% participation in training's against CAPA's.
  6. Responsible for initiation and investigation on LIR, OOS, OOT & boarder line results and reporting them to the in-charge.
  7. Supporting to share required documents from QC to RA/ other requirement.
  8. Determining team priorities in accordance with the plant's needs, while coordinating with the team leader/Manager.
  9. Follow up the housekeeping, cGMP, GLP and Safety Guideline in laboratory.
  10. Signing on approved column in data books, laboratory control card and signing on hard copies as well as approval in LIMS based on requirement.
  11. Responsible for calibration and verification of instruments.
  12. Maintaining of reserved samples room and chambers.
  13. Help in preparation of documents related to department (like STP's, SOP's etc.)
  14. Ensure the sampling of finished products, Raw material, Intermediate and sending sample to outside laboratory for analysis.
  15. Must be ensured sampled, approved and rejected labels timely as required.
  16. Responsible to maintain the stock record of chemicals and reconciliation of standards.
  17. Responsible to maintain safety CAPA.
  18. Responsible to maintain 5-S in QC.
  19. Online documentation (based on requirement) must be ensured as per data integrity norms and awareness to team against data integrity.
  20. Responsible to support analysis reduction/QC efficiency enhancement programs.
  21. Any other job assigned by the Manger - QC Manger or group leader-QC.

Qualifications

The ideal candidate will have: 

  • Education: B.Sc, M.Sc. in Chemistry or B.Pharma.

  • Experience: Minimum 10 years of industrial experience.

  • 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

  • B.Sc or M.Sc in Chemistry or B.Pharm
  • Minimum 10 years of industrial experience
  • Hands-on HPLC experience and ability to perform analytical tests per monograph/SOP
  • Knowledge of cGMP and GLP and QMS activities including audit readiness
  • Experience with LIMS and online documentation with data integrity awareness
  • Experience initiating and investigating OOS, OOT, LIR and related reporting
  • Instrument calibration and verification experience
  • Experience in API/Pharma industry
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The Company
4,100 Employees

What We Do

TAPI is a global leader in the development and manufacturing of active pharmaceutical ingredients (APIs), building blocks, and key starting materials (KSMs). The company provides one of the industry's most comprehensive API portfolios and customized CDMO services, utilizing extensive expertise and innovation to drive pharmaceutical progress and ensure the delivery of high-quality, safe and effective medications to patients worldwide.

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