Senior Qc Executive (LAB QA)

Job Description Sr.QC Executive( Lab QA)

Company: Systacare Remedies
Department: Quality Assurance
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.

The candidate should have strong hands-on knowledge of HPLC, Wet Chemistry, laboratory investigations, OOS/OOT handling, CAPA, internal audits, and quality data evaluation.

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 Good 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 systems.
• Coordinate with QC, QA, Production, and other cross-functional departments for effective resolution of quality-related issues.
• Ensure timely closure of investigations, CAPAs, audit observations, and other assigned quality actions.
• Maintain a strong quality culture and promote compliance with GMP, GLP, data integrity, and applicable regulatory expectations.

Required Skills & Competencies

• Strong knowledge of HPLC and Wet Chemistry analytical operations.
• Good understanding of OOS, OOT, deviation, incident, RCA, and CAPA processes.
• Knowledge of laboratory quality systems and GLP requirements.
• Ability to analyze laboratory data and interpret statistical and quality trends.
• Strong investigation and problem-solving skills.
• Good documentation and report-writing skills.
• Ability to coordinate effectively with QA and QC teams.
• Good understanding of data integrity and laboratory compliance requirements.
• Strong attention to detail and ability to work independently.

Preferred Candidate Profile

The ideal candidate should have practical experience in pharmaceutical laboratory QA/QC operations, particularly in analytical laboratories, with exposure to laboratory audits, regulatory inspections, stability studies, OOS/OOT investigations, and CAPA management.

Experience: in Pharmaceutical QA/QC / Analytical Quality Assurance.

What We Offer

• Opportunity to work in a quality-focused pharmaceutical environment.
• Exposure to laboratory quality systems and regulatory compliance.
• Professional growth and development opportunities.
• Collaborative and cross-functional work environment.

Interested candidates may share their updated CV with:
[email removed]