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.
- Solid 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.

Interested Candidates Please share Profiles to [email protected]

📌 Immediate Opening For QC Position (Hyderabad)
🏢 Vimta Labs
📍 Hyderabad