Clinical Quality Assurance Manager (Hybrid)
- Kpr sugar apperals
- 5 to 9 Yrs
- Ahmedabad
- 10 months ago
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Job Description
- Job Title: Clinical Quality Assurance Manager Department: Quality Department Reports to: Quality Director Position Summary The Clinical Quality Assurance Manager (CQAM) is leading in ensuring the Company conducts clinical trials and studies to the highest quality standards, in compliance with applicable international standards, legislation, protocols, Company and Sponsors processes and requirements. Supports the Quality Director (QD) in monitoring all clinical trial / study-related operations that affect quality and compliance. Manages and conducts clinical suppliers assessment and oversight, performs internal and external audits, and contributes to audits the Company receives from Clients and inspections from Competent Authorities. Main Duties & Responsibilities Reviews and provides input in developing and improving the Companys Quality Management System (QMS) and controlled documents about clinical operations. Drafts clinical quality documents Engages in the interpretation and consultation on regulations, guidelines, and standards Ensures clinical trials/studies compliance with GCP, protocols, local and international legislation, Company and Sponsor SOPs, Policies and Guidelines Delivers quality-related training sessions to all staff Conducts clinical suppliers assessment and performance monitoring Conducts clinical trial-specific document audits, as well as on-site and data management audits, as requested Conducts quality check/audit of TMF documents (both paper and electronic), as requested Performs regular checks to ensure clinical trial / study-specific plans are executed Produces clinical trial/study-specific quality metrics to allow executive and operational insights into study teams and Sites performance In collaboration with the Quality Maintenance Manager (QMM) and the Quality Director (QD), ensures deviations, non-conformances and potential non-conformances are properly documented, addressed, and monitored for effectiveness, in compliance with the Companys and the Sponsors related procedures, as applicable Ensures corrective and preventive appropriate action process to quality findings Develops periodic reports describing compliance / non-compliance trends, identifies areas of potential risk and presents to QD Engages in inspection readiness of Sites and operational staff Performs Quality Co-monitoring Visits Contributes to audits the Company receives from Clients and Competent Authorities Engages in clinical trial / study quality review and oversight meetings Complies with the Company's Quality and Information Security Management Systems and applicable national and international legislation, including legislation for data protection Education Requirements Required: A Bachelor's in natural or health sciences or a related field Desirable: A Master of Science in natural or health sciences or related field Required: Certification of knowledge of clinical trials standards (e.g., ICH GCP etc.) Strong advantage: Certification of knowledge of quality assurance standards (e.g., ISO 9001, etc.) Professional Experience requirements Required: Proven experience as a Clinical Quality Assurance Manager / Senior GCP auditor or 5-year minimum experience in quality for clinical trials in CROs and/or pharmaceutical companies Required: Previous experience with GCP system audits, Site and documentation audits and/or regulatory inspections Language Skills Required Excellent command of spoken and written English Other languages are considered an asset Key competencies Great attention to detail and a result-driven approach Reliable and trustworthy Planning and organization skills Outstanding communication and interpersonal skills Problem-solving skills Good knowledge of MS Office and database savvy Advanced numerical skills and understanding of data analysis / statistical methods Ability to deal adequately with stressful situations, flexible timelines and work pressure Team working skills,
Employement Category:
Employement Type: Full timeIndustry: Medical / HealthcareRole Category: Not SpecifiedFunctional Area: Not SpecifiedRole/Responsibilies: Clinical Quality Assurance Manager (Hybrid)Contact Details:
Company: The Leaders HiveLocation(s): Ahmedabad+ View Contact
Keyskills: Quality Management System Clinical Operations GCP SOPs Quality Assurance Auditing Compliance Training Data Management Corrective Preventive Action
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