Quality Assurance Specialist - Auditor

Our Work Matters

At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world.

The Impact You Will Make

The Quality Assurance Auditor (Specialist) demonstrates expertise in core areas of auditing techniques, and considerable knowledge of pharmaceutical, medical device, and combination product regulations and Data Integrity principles. They are responsible for leading the inspection readiness program, planning for internal and external audits, coordinating audit responses, initiating audit CAPAs, and monitoring their timeline closure and effectiveness.

Role Responsibilities

• The essential functions of the position may include but are not limited to: 
• Implement an Inspection Readiness program – design and develop robust systems, resources, standard operating procedures, and in-house capabilities to maintain on-going compliance to regulatory requirements (21 CFR 4, 210, 211, 820, ISO 13485, ICH Q7, ICH Q8, ICH Q9, and ICH Q10)
• Monitor adherence to the quality system requirements and complete necessary documentation for continuous improvement efforts
• Lead Internal Audit program - plan, schedule, conduct, report, and close audit activities ensuring compliance with SOPs and regulatory expectations
• Manage External Audits - plan, schedule, report, and lead the audit war room
• Evaluate audit findings, coordinate responses, initiate CAPAs, distribute reports to operations staff, management, and customers.
• Track and ensure timely closure of quality events arising from internal audits and regulatory inspections
• Monitor Audit CAPA effectiveness and initiate CAPAs in support of continuous improvement efforts
• Provide interpretation and consultation on regulations, guidelines, compliance status, and policies/procedures

Basic Qualifications

• Education: Bachelor’s degree in quality assurance, Pharmacy, Engineering or other science related discipline – COE and/or CQA preferred
• Minimum 8+ years of experience in pharmaceutical, technical, or related areas including GXP and/or Quality Assurance experience. Other equivalent combinations of education, training, and experience may be accepted in lieu of degree
• Considerable knowledge of GXP regulations and quality assurance auditing techniques
• In depth understanding of ALCOA principles and Data Integrity requirements
• Strong interpersonal skills and excellent problem-solving skills.
• Effective organization, communication, and team orientation skills
• Ability to initiate assigned tasks and work independently
• Ability to manage multiple projects and establish effective working relationships with coworkers, managers, and clients
• Self-starter, team player, with strong interpersonal and coaching skills
• Excellent written skills in English. Good verbal communication and ability to coach and provide guidance to others

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