QA Validation Officer/Executive

Galentic Pharma; Gandhidham; On-site; INR 300,000 - 500,000; Full time

Job summary

Galentic Pharma is seeking personnel to plan and execute validation and qualification activities at the Gandhidham site. The role involves supporting instrument calibration, preparing raw data and reports, and contributing to the development of equipment validation protocols at the site.

You will maintain accurate records of all qualification and validation activities, participate in change control processes, deviations, and investigations, and assist in producing SOPs and related documents

Qualifications

• Planning & execution of validation/qualification activity at site.
• Execution/support during instrument calibration at site.
• Preparation of raw data and reports for executed calibration & validation/qualification.
• Involvement in preparation of equipment validation/qualification protocols & reports.
• Maintenance of accurate records of qualification and validation activity at site.
• Involvement in change control initiation, deviations and investigations related to calibration & qualification/validation.

Responsibilities

• Carry out validation/qualification activities as per protocols.
• Support calibration activities and ensure data integrity.
• Prepare and maintain SOPs, annexures, logbooks and related documents.
• Assist in incident, deviation investigations and change controls related to calibration and qualification.

Job description

1. Planning & Execution of Validation/Qualification activity at site.

2. Execution/ support during Instrument calibration at site.

3. Perform equipment validation/ qualification /periodic qualification as per protocols.

4. Preparation of raw data and reports for executed calibration & validation/ qualification.

5. Involve during preparation of equipment validation/ qualification protocols & reports.

6. Maintain accurate record of qualification and validation activity performed at site.

7. Involvement in Change control initiation, Incidence, deviation related and Investigation related to calibration & qualification/validation activity. 8. Master & Issuance of SOPs, Annexures, Logbooks, & other documents.

9. Additional work assigned by HOD.

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