Lead Quality Assurance resource needed to provide quality support for global computer validation projects in the ERP area, such as SAP, under the guidance of the Global Quality Computer Compliance team.
Job duties will include:
Education/Training/Work Experience:
The position requires a Bachelor’s Degree in Engineering or Sciences with a minimum of 5-8 years experience working in life sciences industry with focus in the area of Quality Assurance.
Experience working with various GxP Enterprise Computerized Systems (on-premise and Cloud based (SaaS) COTS) used in the life sciences industry. Candidate must be well-versed with Software Development Life Cycle (SDLC) methodologies such as Waterfall and V-model. In-depth knowledge of US FDA regulations, ISO standards, MHRA and EU regulations (including Annex 11), and ICH guidelines and Drug Development Life Cycle process. Extensive experience developing and using risk based approaches for computer systems validation. Experience in managing multiple projects and determined to get job done correctly and on time.
All your information will be kept confidential according to EEO guidelines.
Job details are sourced from the employer's original posting.
Open job postingAbout the company
Established in 2000, A Minority Business Enterprise (MBE), LanceSoft Inc. is a pioneer in providing premium end-to-end Professional IT/Non-IT Contingent Workforce Solutions and IT Services to diverse clients across various domains. Core Service Offerings We offer a gamut of services across diverse domains, categories, skill sets with varying lengths of assignments, that include, but are not just limited to: - Temporary Staffing - Permanent Staffing - Payrolling - Recruitment Process Outsourcing (RPO) - Back-office Services - Application Design and Development - Website Design and Development - Program/Project Management Our Domain Strength With currently over 1000+ staff serving over 49 clients worldwide including “Fortune” companies, LanceSoft serves a wide array of industries including Healthcare/Pharma, Clinical/Medical Devices, Technology, Telecom, Retail and Distribution, Energy & Utilities, Banking, Finance, Insurance, Manufacturing, Automobile, Media, Transportation, and Government Sectors. Geographic Coverage LanceSoft is headquartered in Herndon, Virginia and has a network of branch offices across the US in Chicago (IL), Irving (TX), Basking Ridge (NJ), Atlanta (GA) and San Diego (CA). We also have an International footprint with two country offices in Canada (ON and BC) along with three delivery centers in India- Bangalore, Indore and Hyderabad to further help serve our clients better. We currently operate and recruit in 49 US states catering to diverse Contingent Workforce needs of our clients. Awards and Accolades Following are some of our awards and accolades in the US Contingent Workforce space: - Manpower “Premier Vendor” – 2014 - Kelly’s “Supplier Innovation Award” – 2012 - Kelly’s “Supplier of the Year” Award – 2012 and 2011 - Kelly’s “Service Excellence Award” – 2010 and 2009 - “Stewardship Recognition” from Johnson & Johnson’s (J&J) Kelly Work sense program Specialties IT/Non-IT Contingent Workforce Services, Creative Solutions, Temporary/Permanent Staffing, Recruitment Process Outsourcing, Payrolling, Application Design and Development, Back-office Services, Program/Project Management, Website Design and Development