Greetings from Business Integra..!!!
Hope you are doing well!
My name is Aman Gupta and I work for Business Integra Inc. This is a leading IT Staffing (CMMI Level 5) organization. I found your resume in my Database/Job Portal and wanted to get in touch with you to see if you are looking for a new project and you seem to be a good fit for this role, If this Position sounds interesting and something that you feel you would enjoy being a part of, please send me an updated copy of your resume, your hourly/annual salary expectation and best time to reach you over the phone for more discussion
Position: Quality Assurance, Regulatory Affairs and Compliance
Client: NTT Data/Thermo Fisher Scientific
Duration: 6-12+ Months (Possible Extension)
Location: Pittsburgh, PA (100% Remote)
Interview: 2 Video Interviews
POSITION OVERVIEW : Job Description Required Skills: 10+ years as an IT Quality Assurance Specialist within Pharma/Lifesciences
Ability to work on multiple concurrent projects Ability to work effectively in a fast-paced geographically dispersed team setting Ability to work successfully with cross functional teams Experience with use of MS Office Tools e.g., PowerPoint, VISIO, MS Word, Excel, Outlook, TEAMS
10+ years of CSV (Computer System Validation) experience for GAMP-5 category 3, 4, and 5 Working knowledge of GxP Processes Experience in infrastructure qualification Experience with Quality Systems (e.g. change control, deviations, testing defects, CAPA)Ability to work within a fast-paced, large company environment Excellent written and oral communication skills, presentation skills, and soft skills Responsible for performing an independent quality review and approval of computer system validation and infrastructure qualification deliverables in alignment with internal procedures and government regulations Support computer system validation projects and the validation lifecycle of existing and new computerized systems used for pharmaceutical and biotech processes[a name='_Hlk75437576']Knowledge with quality and IT frameworks, approaches, tools, methodologies (i.e., GAMP, ISO, ITIL, SDLC, COBIT, Computer Software Assurance (CSA) etc.)Understanding of Quality, Regulatory and Compliance best practices including knowledge of 21 CFR Parts 11, 210, 211 requirements, Data Integrity, ICH Q7A requirements, and GAMP 5Must have an advanced understanding of the validation and qualification lifecycle and all applicable phases including planning, testing, reporting and change control Able to analyze and propose solutions for compliance issues and deviations Experience in the use of Application Lifecycle Management (ALM) or other automated testing tools is desirable
NICE TO HAVE
- TrackWise Digital System experience
- Bachelor’s Degree in Computer Science or equivalent combination of education and experience.
POSITION GENERAL DUTIES AND TASKS : Job Description Required Skills
- 10+ years as an IT Quality Assurance Specialist within Pharma/Lifesciences
- Ability to work on multiple concurrent projects Ability to work effectively in a fast-paced geographically dispersed team setting Ability to work successfully with cross functional teams Experience with use of MS Office Tools e.g. PowerPoint, VISIO, MS Word, Excel, Outlook, TEAMS
- 10+ years of CSV (Computer System Validation) experience for GAMP-5 category 3, 4, and 5 Working knowledge of GxP Processes Experience in infrastructure qualification Experience with Quality Systems (e.g. change control, deviations, testing defects, CAPA) Ability to work within a fast-paced, large company environment Excellent written and oral communication skills, presentation skills, and soft skills
Thanks & Regards,
Aman Gupta
Recruitment Team Lead at Business Integra Inc.
E: aman.gupta@biitservices.com W: www.businessintegra.com
A: 6550 Rock Spring Dr., Suite # 600 Bethesda, MD 20817
LinkedIn: https://www.linkedin.com/in/aman-gupta-4045a080/
CMMI Level 5 | A WBE | DBE/MBE Corporation
8(a) | ISO 9001-2008 | GSA Schedule 70
