Software Guidance and Assistance, Inc.
CSA Validation Subject Matter Expert (SME)
Software Guidance and Assistance, Inc., Long Island City, New York, United States, 11101
Software Guidance & Assistance, Inc., (SGA), is searching for an CSA Validation Subject Matter Expert (SME) for a
RIGHT TO HIRE
assignment with one of our premier
Beauty
clients in LIC
, New York.
Responsibilities
: The CSA Validation SME is a key stakeholder in the ELC CSA Center of Excellence (COE). The primary function of this role is to ensure the integrity of CSA projects, with an eye to assessing risk and ensuring integrity. Their responsibilities serve as a key conduit between the COE leadership and the protocol author(s) and tester(s). The CSA Validation SME will ensure validation projects meet regulatory and data integrity requirements, and they will confirm validation projects meet R&D/GSC/IT policies.
Responsibilities: • Provide insight and expertise on validation project risk and complexity • Maintain validation best practices • Gather project information from system owner(s) • Collaborate with the Business Analyst on a frequent basis • Maintain compliance with Good Documentation Practices (GDP) • Aid in writing and reviewing of reports summarizing system CSA validation execution • Collect feedback from System Owner(s) on deliverables • Draft and execute of GxP Assessment, Risk Assessment (RA), Validation Plan (VP), Test Plan (TP), and Validation Summary Report (VSR) as necessary • Draft, review, and execute other validation documents when necessary
Qualifications: • Bachelor's Degree in Computer Science, Information Technology, Chemical Engineering, Biomedical Engineering, or related degree • 7-10+ years of successful, progressive experience with Computer System Validation and Computer Software Assurance • Aptitude in GAMP 5 and 21 CFR Part 11 standards • Previous experience in a GxP industry or a life sciences industry is required • Technical competency in FDA regulations • Expertise in generating, reviewing, and addressing CAPAs • Strong written and verbal communication skills • Strong ability to collaborate with the team • Ability to work self-directed in the timely completion of project deliverables • Practical experience with Data Integrity and ALCOA+ is a plus
Demonstrated Competencies: • Technical Competency - Develop an understanding of business requirements and work to translate the business requirements to the necessary CSV documents and supporting materials • Time Management - Able to follow strict deadlines, prioritize tasks, and work well under pressure • Analytical Skills - Identifies, researches, and demonstrates logical reasoning to communicate critical information • Agility - Meets objectives by responding to competing and changing priorities and multiple tasks under inflexible timelines • Strong written and verbal communication skills • Strong ability to communicate with other COE team members • Strong analytical and problem-solving abilities • Understands the purpose of CSA, is passionate about customer safety, data integrity, and product quality • Adept at solution development and project scoping • Effectively collaborate with peers, cross-functional teams, and departments • Strong technical background is preferred
Must Have: Extensive experience in the Medical, Pharma or Regulatory Compliance Industries Strong CSA experience as they will be acting as the SME Must have good communication and leadership skills, collaboration skills, must have a positive attitude and be easy to work with Agile experience/knowledge highly preferred.
SGA is a technology and resource solutions provider driven to stand out. We are a women-owned business. Our mission: to solve big IT problems with a more personal, boutique approach. Each year, we match consultants like you to more than 1,000 engagements. When we say let's work better together, we mean it. You'll join a diverse team built on these core values: customer service, employee development, and quality and integrity in everything we do. Be yourself, love what you do and find your passion at work. Please find us at https://sgainc.com/ .
SGA is an Equal Opportunity Employer and does not discriminate on the basis of Race, Color, Sex, Sexual Orientation, Gender Identity, Religion, National Origin, Disability, Veteran Status, Age, Marital Status, Pregnancy, Genetic Information, or Other Legally Protected Status. We are committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, and our services, programs, and activities. Please visit our company EEO page to request an accommodation or assistance regarding our policy. #LI-JM1
RIGHT TO HIRE
assignment with one of our premier
Beauty
clients in LIC
, New York.
Responsibilities
: The CSA Validation SME is a key stakeholder in the ELC CSA Center of Excellence (COE). The primary function of this role is to ensure the integrity of CSA projects, with an eye to assessing risk and ensuring integrity. Their responsibilities serve as a key conduit between the COE leadership and the protocol author(s) and tester(s). The CSA Validation SME will ensure validation projects meet regulatory and data integrity requirements, and they will confirm validation projects meet R&D/GSC/IT policies.
Responsibilities: • Provide insight and expertise on validation project risk and complexity • Maintain validation best practices • Gather project information from system owner(s) • Collaborate with the Business Analyst on a frequent basis • Maintain compliance with Good Documentation Practices (GDP) • Aid in writing and reviewing of reports summarizing system CSA validation execution • Collect feedback from System Owner(s) on deliverables • Draft and execute of GxP Assessment, Risk Assessment (RA), Validation Plan (VP), Test Plan (TP), and Validation Summary Report (VSR) as necessary • Draft, review, and execute other validation documents when necessary
Qualifications: • Bachelor's Degree in Computer Science, Information Technology, Chemical Engineering, Biomedical Engineering, or related degree • 7-10+ years of successful, progressive experience with Computer System Validation and Computer Software Assurance • Aptitude in GAMP 5 and 21 CFR Part 11 standards • Previous experience in a GxP industry or a life sciences industry is required • Technical competency in FDA regulations • Expertise in generating, reviewing, and addressing CAPAs • Strong written and verbal communication skills • Strong ability to collaborate with the team • Ability to work self-directed in the timely completion of project deliverables • Practical experience with Data Integrity and ALCOA+ is a plus
Demonstrated Competencies: • Technical Competency - Develop an understanding of business requirements and work to translate the business requirements to the necessary CSV documents and supporting materials • Time Management - Able to follow strict deadlines, prioritize tasks, and work well under pressure • Analytical Skills - Identifies, researches, and demonstrates logical reasoning to communicate critical information • Agility - Meets objectives by responding to competing and changing priorities and multiple tasks under inflexible timelines • Strong written and verbal communication skills • Strong ability to communicate with other COE team members • Strong analytical and problem-solving abilities • Understands the purpose of CSA, is passionate about customer safety, data integrity, and product quality • Adept at solution development and project scoping • Effectively collaborate with peers, cross-functional teams, and departments • Strong technical background is preferred
Must Have: Extensive experience in the Medical, Pharma or Regulatory Compliance Industries Strong CSA experience as they will be acting as the SME Must have good communication and leadership skills, collaboration skills, must have a positive attitude and be easy to work with Agile experience/knowledge highly preferred.
SGA is a technology and resource solutions provider driven to stand out. We are a women-owned business. Our mission: to solve big IT problems with a more personal, boutique approach. Each year, we match consultants like you to more than 1,000 engagements. When we say let's work better together, we mean it. You'll join a diverse team built on these core values: customer service, employee development, and quality and integrity in everything we do. Be yourself, love what you do and find your passion at work. Please find us at https://sgainc.com/ .
SGA is an Equal Opportunity Employer and does not discriminate on the basis of Race, Color, Sex, Sexual Orientation, Gender Identity, Religion, National Origin, Disability, Veteran Status, Age, Marital Status, Pregnancy, Genetic Information, or Other Legally Protected Status. We are committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, and our services, programs, and activities. Please visit our company EEO page to request an accommodation or assistance regarding our policy. #LI-JM1