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.