HomeProductionManager/Sr Manager - Quality Assurance | Troikaa Pharmaceuticals | Ahmedabad

Manager/Sr Manager – Quality Assurance | Troikaa Pharmaceuticals | Ahmedabad

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1983 was the year in which Troikaa was founded. Commercial activities started in the year 1984. The beginnings were modest. We had a small factory & employee strength of the company was 15. Constant innovation & aggressive marketing have resulted in steady growth for Troikaa. Today we can boast of an impressive corporate office at Ahmedabad, Gujarat. Three State-of-the-art manufacturing facilities in Gujarat and Uttarakhand, Six marketing divisions & more than 2300 employees.

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The people are the strength of an organization. But having the right people in the right places makes our organization much stronger, healthier, and highly competitive. Each department is headed by a technocrat. The organization’s steady & fast growth is proof of having the right people at the helm of affairs.

In recognition of the individual contribution, we felicitate every contributing member with a suitable reward. Our reward system creates healthy competition and sets high standards.

Position: Manager/Sr Manager – Quality Assurance

Location: Virochannagar, Sanand, Ahmedabad, Gujarat

Job Description:

Troikaa Pharmaceuticals Limited invites applications for Manager / Sr. Manager – QC for Virochannagar (Sanand) formulation facility.

  • Responsible for IP, FP & Stability section and the daily work allocation with co-ordination with Production and IPQA department
  • Review and execute Protocols, Standard Operating procedures (SOPs), General test procedures (GTPs)
  • Monitoring Procedures, Specifications, Test datasheet, Stability study protocols/data, AMV / Tech transfer documents, Analytical data, COA and Calibration of the instruments
  • Prepare and review regulatory documents from the Quality Control Department required for Regulatory submission purpose (ANDA & Site transfer Products).
  • Planning the analysis, Review, and release of quality control samples like RM/IP/FP/Stability samples
  • Troubleshooting & calibration of instruments like HPLC, GC, FTIR, UV/VIS Spectrophotometer, Digital polarimeter, Autotitrator, KF apparatus, Dissolution test apparatus, etc.

  • Responsible for OOS, OOT, laboratory incidences, Change controls, Deviations.
  • Prepare SOPs, STPs, GTPs, Specifications, standard test procedures, and Quality Control documents.
  • Prepare and Review documents required for regulatory filling from the Quality Control Department
  • Responsible to ensure compliance & no data integrity issues in quality control.
  • Responsible to ensure that the staff performing the activities is adequately trained as per the current procedures.
  • Responsible for audit trail and message center review.
  • Primary/ Reference / Working standards, Volumetric reagent / solutions
  • Responsible for Compilation and review of stability Compilation sheet required for regulatory filling.
  • Responsible to uphold the Good Laboratory Practices in quality control laboratory as per current USP regulatory guidelines.
  • Thorough knowledge on HPLC chromatographic process and software controls.
  • Responsible to ensure the accuracy of the documents review of the initial reviewer.
  • Responsible to review and escalate the completion of chromatographic data processing, reporting, and review and ensure the correctness of the data transcription.
  • Responsible to evaluate the test results against the trends and escalate Out of Trend Result.
  • Responsible for effective review of Out of Specification (OOS) / Out of Trend (OOT) result and able to evaluate root causes and appropriate CAPAs.
  • Responsible for the review of stability data at different conditions viz. accelerated, intermediate, and long-term as per ICH guidelines.
  • Responsible for the review of Laboratory Investigation Reports, Quality events, deviations, Standard Operating Procedures Standard test procedures.
  • Responsible for overall monitoring, planning, troubleshooting & co-ordination with other departments for smooth function of quality control laboratory.
  • Responsible for Handling of regulatory as well as external audits and ensuring timely compliance to the audit observation if any. Also, ensure the compliance of audit observation and to participate in self-inspection.

Qualification: B.Sc/B.Pharma/MS/M.Sc, M.Pharma

Experience: 10-16 Years

Salary: Negotiable

Contact Details:

career@troikaapharma.com

OR

Click Here to Apply Directly on Company’s Website

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