Quality Control - Administration

Role & responsibilities

SOP and Document Control

• Review departmental SOPs, formats, annexures and controlled documents for compliance, adequacy and consistency; coordinate timely revision and issuance.
• Maintain documents as per the approved document control system, including agreements, AMC/service contracts and PTR records with due-date tracking.
• Support preparation and review of change controls, deviations, CAPA and related quality documentation.

Record, Logbook & QC Monitoring

• Conduct periodic QC review of departmental logbooks and records for completeness, accuracy, traceability and timely entry.
• Identify documentation errors and overdue activities; communicate observations and follow up on CAPA to closure.
• Perform monthly (or as-required) QC monitoring; prepare and maintain monitoring records and reports.

Training & Awareness

• Support induction and refresher training for departmental personnel and monitor training compliance for applicable SOPs.
• Promote awareness of documentation practices, quality requirements and safety compliance.

Audit & Inspection Readiness

• Maintain audit/inspection readiness for sponsor, client and internal, external and regulatory reviews; organize and retrieve required records.
• Participate in audits, support response preparation (RCA/CAPA) and ensure timely closure of audit commitments.
• Taking monthly all facility round & preparing observation report.

Compliance & Continuous Improvement

• Monitor compliance with departmental SOPs, policies and quality requirements; escalate compliance risks as needed.
• Participate in risk assessment activities and identify opportunities to improve documentation, processes and quality systems.

Coordination & Other Responsibilities

• Coordinate with Administration, Maintenance, QA and other departments; maintain periodic reports and trackers.
• Perform other quality-related or departmental duties as assigned by the Head AMD.

Soft Skills

• Integrity, transparency and professional confidentiality in handling quality and organizational information.
• Strong attention to detail with the ability to identify errors, gaps and inconsistencies during review.
• Ownership and accountability for assigned activities, with proactive follow-up on pending actions.
• Clear written and verbal communication of observations, requirements and expectations to stakeholders.
• Collaborative, professional approach with Administration, Maintenance, QA and other departments, including during audits.
• Logical, analytical problem-solving to identify root causes and recommend practical corrective actions.
• Effective planning and prioritization of QC activities based on risk, urgency and timelines.
• Adaptability to evolving procedures and regulations, with commitment to continuous learning.
• Professional composure under pressure while managing multiple responsibilities.

Technical Skills

• Working knowledge of QMS principles, document control, deviation, CAPA, change control and risk assessment processes.
• SOP preparation, review, revision, amendment and lifecycle/effective-date management.
• Good documentation practices, data integrity principles and record traceability/retention requirements.
• Planning, execution and reporting of periodic QC monitoring, checklists and observation tracking.
• Internal, sponsor/client, external and regulatory audit/inspection readiness, including observation response preparation.
• Basic risk-based approach to identifying compliance gaps and assessing process/documentation impact.
• Working knowledge of facility, maintenance, AMC/vendor documentation, and safety, security, pest-control and fire-safety compliance.
• Proficiency in MS Word, Excel and PowerPoint; familiarity with electronic QMS/document management systems, trackers and dashboards.