02 Sep
|
Systacare Remedies
|
Majitha
02 Sep
Systacare Remedies
Majitha
Job Description Sr.QC Executive( Lab QA)
Company: Systacare Remedies
Department: Quality Assurance/Quality Control
Position: Lab QA / Quality Assurance Laboratory
Qualification: B.Pharm / M.Pharm / M.Sc. / B.Sc. in Chemistry or relevant discipline
Job Summary
Systacare Remedies is looking for a competent and detail-oriented Lab QA professional to oversee laboratory quality systems, ensure compliance with GLP and applicable regulatory requirements, and support effective investigation and resolution of laboratory-related quality issues.
Key Responsibilities
- Monitor and review internal laboratory QC data, track quality indicators, and evaluate relevant statistical quality metrics.
- Possess in-depth knowledge of HPLC operations, analytical testing, and Wet Chemistry activities.
- Review, update, and monitor stability data and support interpretation and evaluation of Out-of-Trend (OOT) results in coordination with the QA Department.
- Conduct internal laboratory audits and ensure compliance with approved procedures, specifications, GLP, and applicable regulatory requirements.
- Support and coordinate regulatory inspections and customer audits, ensuring laboratory readiness and timely closure of observations.
- Verify adherence to Positive Laboratory Practices (GLP) and established laboratory procedures.
- Lead and coordinate Root Cause Analysis (RCA) for Out-of-Specification (OOS) results, OOT results, deviations, laboratory errors, and other non-conforming events.
- Ensure proper documentation and scientifically sound evaluation of laboratory investigations.
- Develop, implement, monitor, and track Corrective and Preventive Actions (CAPA) arising from investigations, audits, deviations, and quality events.
- Review laboratory documentation, analytical records, logbooks, worksheets, and other relevant quality records for compliance and completeness.
- Identify recurring quality issues and recommend continuous improvement initiatives for laboratory processes and system
📌 Senior Qc Executive (Majitha)
🏢 Systacare Remedies
📍 Majitha