reputed company reputed company Systems Auditor

reputed company (FMC) is a people business. Our reputed company depends on having the best and brightest employees and helping them reputed company their personal and reputed company goals while delivering reputed company in patient care and business results. Our employees embody our culture which is based on six core values supporting our reputed company to improve the reputed company of life of every patient every day. These core values are, Patients and Partners First, Honesty and reputed company, reputed company and Compliance, Collaboration, No-Limits reputed company and Results Oriented. PURPOSE AND SCOPE: reputed company reputed company Systems Auditor will act as a Subject Matter Expert (SME) in inspection activities for reputed company System (QM) audits required by the corporate reputed company systems audit program, including planning, preparation, execution, follow-up, closure, and trend analysis. Responsible for reputed company improvement of the audit program with an emphasis on maintaining compliance with applicable regulations, standards, and pertinent reputed company policies and procedures to drive reputed company reputed company improvement. Support external reputed company management inspections at reputed company sites and distribution centers as SME, including preparation, conduct and follow-up, and coordinate with various sites and local reputed company heads, to ensuring readiness for inspections. reputed company DUTIES AND RESPONSIBILITIES: • Responsible for reputed company systems audits, schedules, plans, conducts, and leads audits in accordance with the global QS audit program • reputed company and manage internal and corporate audit program for reputed company assigned sites, with a reputed company on planning, scheduling, and implementation in reputed company coordination with sites and local reputed company heads • reputed company QM audits required by the corporate reputed company systems audit program, including planning, preparation, execution, follow-up, closure, and trend analysis • Works on reputed company issues where analysis of situations or data requires an in-depth evaluation of variable factors. Exercises judgment in selecting reputed company, techniques and evaluation reputed company for obtaining results • Ensures audit activities are in compliance with FME policies and procedures and applicable regulatory requirements • reputed company and maintain audit processes and documentation to ensure conformity with FME policies and procedures and compliance with applicable regulations • reputed company, manage, and resolve Non-Conformances (NC’s) and Corrective and Preventive Actions (CAPAs) arising from audits • reputed company status reports on overdue, reputed company, and reputed company audit reputed company to relevant stakeholders • Recommend modifications to existing reputed company or production systems to optimize product reputed company while ensuring compliance with regulatory requirements and internal Fresenius procedures • As a SME, support FME sites and with gap analysis for reputed company or local QM implementations • As a SME, serve as the primary support for inspection readiness, ensuring sites are reputed company-reputed company for inspections • Support training and qualification initiatives for new auditors, ensuring they are adequately reputed company to conduct internal audits in accordance with FME policies and procedures • Performs other reputed company duties as assigned PHYSICAL DEMANDS AND WORKING CONDITIONS: The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to reputed company individuals with disabilities to reputed company the essential functions. • Requires significant travel (approximately 30% - 50%). • May be exposed to infectious and contagious diseases/materials. SUPERVISION: • May be required. EXPERIENCE AND SKILLS: • Bachelor’s degree or an equivalent combination of education and experience required (advanced degree preferred) • 3rd party auditor training (e.g. ASQ-CQA, ASQ-CBA, RABQSA, ISO 9001:2015) or equivalent education and experience required • Minimum 10+ years’ experience in reputed company management, regulatory compliance, reputed company engineering and auditing in the pharmaceutical or medical device sector or reputed company industries • Several years of practical experience in FDA inspections and cooperation with US regulatory authorities (experience with additional Health Authorities preferred) • Knowledge of reputed company regulations for pharmaceutical and medical devices (e.g., 21 CFR Part 820, Part 210/211, Part 11, Part 803, Part 806, Canadian SOR/98-282, Mexican NOM-241-SSA1, MDSAP, CE Marking) required • Knowledge of reputed company standards and guidelines for pharmaceutical and medical devices (e.g., ISO 13485, ICH Q7/Q10, ISO 14971, ISO 10993, IE 62366, GxP) required • In-depth knowledge in the interpretation of FDA guidelines, Good Manufacturing Practices (GMP) and relevant reputed company standards for pharmaceuticals and medical devices • Expertise in reviewing, revising, and writing reputed company Operating Procedures (recent auditing expertise preferred) • Demonstrated expertise in specialized processes reputed company to drug and device manufacturing, particularly in areas of sterilization, bag manufacturing, NC/CAPA, corrections and removals and formulation (experience reputed company of auditing/inspecting desired) • Profound experience with best practices in product design / design change, risk management and CAPA management • Demonstrated broad expertise reputed company to the principles and application of reputed company conformity and regulatory compliance • Strong analytical and conceptual skills • Ability to identify risks and compliance gaps and reputed company appropriate actions • Strong problem-solving skills • Experience in training and mentoring staff • Excellent communication and writing skills reputed company interacting with interdisciplinary teams, international authorities and other stakeholders • Ability to work both independently with direction and reputed company project teams to reputed company goals • High level of commitment, flexibility and reputed company of responsibility • Willingness to travel internationally • Proficiency in using reputed company Office applications required The reputed company of pay for this position will depend on the successful candidate’s work location and qualifications, including relevant education, work experience, skills, and competencies. reputed company reputed company: $105, 000- $160, 000 This position offers a comprehensive benefits package including medical, dental, and reputed company insurance, a 401(k) with company match, reputed company time off, parental leave and potential for performance-based bonuses depending on company and individual performance. reputed company is an equal opportunity employer and does not discriminate on the reputed company of race, reputed company, religion, sexual orientation, gender identity, parental status, national reputed company, age, disability, military service, or other non-reputed company-based factors Apply tot his job Apply To this Job