Officer Quality Assurance

Thornton Tomasetti

Solan

On-site

INR 650,000 - 950,000

Full time

4 days ago
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Job summary

Thornton Tomasetti in India seeks an Officer Quality Assurance to ensure GMP/GDP compliance within an oral dosage facility, perform IPQA line clearance, and manage in-process checks during batch manufacturing and packing.

You will handle sample management, issue batch records, calibrate IPQA instruments, and support investigations, with ISOtrain SOP training and a focus on safety practices.

Qualifications

  • Knowledge of current Good Manufacturing Practices in oral dosage manufacturing.
  • Understanding GDP and data integrity in QA processes.
  • Experience with batch manufacturing and coating records a plus.

Responsibilities

  • Ensure GMP/GDP compliance in the oral dosage facility and data integrity.
  • Oversee manufacturing and packing processes per BMR/BPR.
  • Perform line clearances and in-process checks at stages of batch production.
  • Manage collection and records for control, stability, validation, and other samples.
  • Issue batch records and review executed batch documents.
  • Issue controlled copies of logbooks and formats.
  • Ensure IPQA SOP adherence and related records.
  • Calibrate IPQA instruments and maintain calibration records.
  • Assist investigations and participate in safety training per ISOtrain.
  • Follow COBC and safety practices; serve as designee when needed.

Skills

GMP compliance
IPQA knowledge
Data integrity
Quality assurance

Tools

ISOtrain

Job description

## Officer Quality AssuranceApply: India > Village Mauza : Baddi: Full time: Posted Today: 31164037## **JOB DESCRIPTION:**Followings will be the responsibilities of the position holder:1. Compliance of current Good Manufacturing Practices in the Oral dosage facility & to follow GDP with data-integrity compliance. 2. Manufacturing and Packing process compliance in accordance with approved BMR/BPR. 3. To carry out line clearance, In-process checks at the different stages of batch manufacturing and packing. 4. Collection and management of control samples / stability samples / validation samples / other samples (as applicable) and maintain their record. 5. Issuance of Batch records and review of executed batch documents.* undefined6. Issuance of controlled copies of Logbooks and formats. 7. Compliance of IPQA related SOPs and records. 8. Calibration of IPQA instruments and to maintain related records. 9. To assist investigation activities. 10. SOP training in ISOtrain of self-train within stipulated time.* undefined11. To follow all the practices related to safety and COBC.In absence of the position holder, designated Executive-IPQA shall be authorized designee and responsible for day to day working.**The base pay for this position is**N/AIn specific locations, the pay range may vary from the range posted.## **JOB FAMILY:**Operations Quality## **DIVISION:**EPD Established Pharma## **LOCATION:**India > Village Mauza : Baddi## **ADDITIONAL LOCATIONS:**## **WORK SHIFT:**Standard## **TRAVEL:**Not specified## **MEDICAL SURVEILLANCE:**Not Applicable## **SIGNIFICANT WORK ACTIVITIES:**Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day)
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