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SAP SE
Philadelphia, PA, United States
SAP innovations help more than four hundred thousand customers worldwide work together more efficiently and use business insight more effectively. Originally known for leadership in enterprise resource planning (ERP) software, SAP has evolved to become a market leader in end-to-end business application software and related services for database, an
Job Source: SAP SEHealth Partners Plans
Philadelphia, PA, United States
Why Choose Jefferson Health Plans? We are an award-winning, not-for-profit health maintenance organization offering Medicaid, Medicare, and Children's Health Insurance Program (CHIP) plans that include special benefits to improve the health and wellness of our members. We are committed to creating a community where everyone belongs, acknowledges, a
Job Source: Health Partners PlansTATA ELXSI
Philadelphia, PA, United States
Job duties as a Computer Systems Architect: Engaging in requirements gathering and technical discussions (15%) Analyzing the requirements and conducting a detailed feasibility study of the same (3%) Understanding the different premium apps that need to be integrated on the platform and understanding their dependencies in detail (7%) Preparing the d
Job Source: TATA ELXSIArchdiocese of Philadelphia
Philadelphia, PA, United States
This job description explains the detail and general nature of the position; and overview of why the job exists and what the job is to accomplish. Job title Safe Environment Compliance Auditor, Full-Time Reports to Director and Assistant Director Location Office for Child and Youth Protection Overtime Non-Exempt, Based on Job Duties Job pu
Job Source: Archdiocese of PhiladelphiaPhiladelphia Gas Works
Philadelphia, PA, United States
Overview Philadelphia Gas Works Looking for a challenge and ready to power up your career? Free Health Insurance Options– Free Dental Insurance – Flex Spending - Commuter Benefits - Pension Plan – Free Parking – Wellness Programs – Onsite Gyms – Tuition Assistance- PSLF Eligible Employer- Parental Leave- Hybrid Work Environment The Philadelphi
Job Source: Philadelphia Gas WorksCharles River Laboratories
Wayne, PA, United States
For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your ski
Job Source: Charles River LaboratoriesCharles River Laboratories
Wayne
For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your ski
Job Source: Charles River LaboratoriesCharles River Laboratories
Wayne, PA, United States
Manage computerized system validation activities in CRL Manufacturing Operations, ensuring compliance and quality in equipment and software. Responsible for documentation maintenance and serving as a resource for validation team members, contractors, and vendors. Responsibilities: Lead full lifecycle of validation projects, delivering on time and
Job Source: Charles River LaboratoriesPhiladelphia, PA, United States
Job Description Job Description Company Description
ADAMAS is a well-established, leading provider of mission-critical regulatory compliance and consulting services to the global pharmaceutical industry. It operates across Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP), Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP) and Computer Systems Compliance (CSC) (together, GxP).
Founded in 2007, ADAMAS has focused on ensuring that the highest standards of best practice are attained across the pharmaceutical sector. ADAMAS has an established client base with an expansive global reach, including North America,Europe,and Asia Pacific. We work with over 100 currently active clients and have worked with over 700 pharmaceutical companies, including 40 of the 50 largest global pharma and biotech companies.
At ADAMAS, our people are our primary asset. We possess the highest and broadest level of in-house knowledge and can deliver genuine expertise and experience globally via in-house resources. ADAMAS's success is down to the calibre of its people – to reward them we offer a competitive salary with benefits, excellent working conditions and a fulfilling and rewarding career, with plenty of opportunities for further development.
Job Description
Planning, preparation, conduct, reporting and follow up of various types of audits according to expected quality and timelines
Executing audits based on a comprehensive understanding of all regulatory requirements.
Performing quality assurance projects on behalf of client companies within the pharmaceutical/biotechnology industry.
Assisting with business development activities
Qualifications
BSc in Life Science preferred
Experience in conducting and leading internal and external Computer System Compliance audits for a variety of stakeholders
Experience in conducting a range of service provider audits (e.g., computer system validation audits, computer system compliance audits)
Experience in conducting CSC/CSV systems audits.
Experience in coordinating and managing inspection preparation activities om support of regulatory inspections both at the sponsor and CRO.
Expert knowledge of national and international computer system legislation and guidelines
Up to 40% travel and ability to conduct remote audits
Additional Information
Why ADAMAS?
As an organization, we prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds, genders and ages can contribute and grow.
To succeed we must work together with a human first approach. Why? Because our people are our greatest strength leading to our continued success on improving the lives of those around us.
We offer:
Training and career development opportunities internally
Strong emphasis on personal and professional growth
Friendly, supportive working environment
Opportunity to work with colleagues based all over the world, with English as the company language.
Our core values are key to how we operate, and if you feel they resonate with you then ADAMAS, an Ergomed Company is a great place to join!
Quality
Integrity & Trust
Drive & Passion
Agility & Responsiveness
Belonging
Collaborative Partnerships
We look forward to welcoming your application.
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Email Alert for Computer System Compliance Auditor jobs in Philadelphia, PA, United States
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