06 Nov
|
Veeda CR
|
Ahmedabad
06 Nov
Veeda CR
Ahmedabad
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.
- Solid 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.
📌 Quality Control - Administration (Ahmedabad)
🏢 Veeda CR
📍 Ahmedabad