Immediate Opening For QC Position

Vimta Labs Ltd.

Hyderabad

On-site

INR 1,200,000 - 1,800,000

Full time

7 days ago
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Job summary

Vimta Labs Ltd. in Shamirpet, Hyderabad, is seeking an experienced QA professional to lead core QMS investigations and ensure data integrity across biopharma operations. The role focuses on investigations, documentation control, and instrument qualification within a compliant environment.

You will review SOPs, manage training documentation, and oversee calibration and maintenance schedules, while ensuring adherence to GxP and regulatory standards. 8–12 years of relevant experience is required.

Qualifications

  • Experience with regulatory compliance in biopharma or analytical testing.
  • Strong data integrity practices and instrument software privileges.
  • Proven RCA experience for OOS/OOE/Deviations.

Responsibilities

  • Lead and participate in QMS investigations of incidents, OOS/OOE/OOX, occurrences and deviations.
  • Review documentation requests and authorize procedural document issuance.
  • Monitor environmental conditions and temperature monitoring in the biopharma department.
  • Author and review SOPs, instrument qualification protocols, raw data, and final reports.
  • Audit and maintain instrument usage and maintenance logs across the department.

Skills

Regulatory compliance (GxP, FDA, MHRA)
Data Integrity principles
Root cause analysis (RCA)

Education

M.Sc./B.Pharmacy/M.Pharmacy

Job description

Dear All,


Greeting From Vimta Labs.


Company Name: Vimta Labs

Location: Shamirpet, Hyderabad

Experience: 8 to 12 Years

Education: M.Sc. / B.Pharmacy / M.Pharmacy


Key Responsibilities Core QMS & Investigations
  • Investigate quality issues: Lead and participate in QMS investigations concerning Incidents, Out of Specification/Expectation (OOS/OOE/OOX), Occurrences, and Deviations.
  • Review documentation requests: Serve as a designee for authorizing procedural document issuance.
  • Monitor environmental conditions: Record and witness temperature monitoring protocols within the biopharma department.

Documentation & Compliance Review
  • Author and review SOPs: Prepare and review Standard Operating Procedures, instrument qualification protocols, raw data, and final reports.
  • Audit logbooks: Perform periodic reviews of instrument usage and maintenance logbooks across the department.
  • Manage standards: Review the usage, maintenance, and tracking of reference standards.

Equipment Qualification & Data Integrity
  • Ensure instrument compliance: Review analytical instrument software user roles, privileges, project-related protocols, and raw data to ensure data integrity.
  • Oversee maintenance schedules: Review equipment lists, calibration schedules, and preventive maintenance (PM) timelines.
  • Verify equipment safety: Review periodic calibrations, PM, and electrical safety protocols for all biopharma equipment.

Training & People Management
  • Deliver training: Provide technical training on system-related procedures and quality management systems to the team.
  • Authorize training records: Act as a designee for the review and authorization of Training Documentation Forms (TDF) and Training Assessment Forms (TAF).

Required Technical Skills & Competencies
  • Deep understanding of regulatory compliance (GxP, FDA, MHRA) in a biopharma or analytical testing environment.
  • Strong expertise in Data Integrity principles and software user-privilege management for analytical instruments.
  • Proven track record in handling complex root cause analysis (RCA) for OOS and deviations.

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