The Contract - QA Computer System Validation Specialist will provide quality oversight to CSV projects including implementation and maintenance of GxP Computerized Systems.
Skills: Work with validation team to determine validation approach and validation deliverables Review Computer System Validation deliverables to ensure compliance and adherence with corporate guidelines procedures, CGMP and ISPE GAMP guidelines and regulations Review and approval of IT change controls, qualification activities, and periodic assessments Review and provide feed to vendor validation documentations (Validation plan, executed protocols, risk assessments) Perform risk assessments with functional teams to assess system risks and develop mitigations Leverage technical experience to streamline the review and oversight process to enable education of system users Provide QA expertise, advice, or assistance, as required Hands-on experience in CSV in the pharmaceutical industry, or related industry In depth knowledge of FDA guidelines and Global cGMPs relevant to 21 CFR Part 11/EU Annex 11 compliance requirements and Global Computer System Validation and ISPE GAMP guidelines Ability to independently identify compliance risks and escalate when necessary Experience with Veeva Systems preferred Excellent interpersonal skills with the ability to influence individual and teams across the organization Strong in Critical Thinking / Problem Solving with the ability to evaluate quality matters and make decisions utilizing risk-based approach Must be flexibility/Adaptable with strong attention to detail
Keywords:
Education: B.S. in scientific or allied health field (or equivalent degree) and 5+ years of relevant work experience Hands-on experience in CSV in the pharmaceutical industry, or related industry In depth knowledge of FDA guidelines and Global cGMPs relevant to 21 CFR Part 11/EU Annex 11 compliance requirements and Global Computer System Validation and ISPE GAMP guidelines Ability to independently identify compliance risks and escalate when necessary Experience with Veeva Systems preferred Excellent interpersonal skills with the ability to influence individual and teams across the organization Strong in Critical Thinking / Problem Solving with the ability to evaluate quality matters and make decisions utilizing risk-based approach Must be flexibility/Adaptable with strong attention to detail Skills and Experience:
Required Skills:
CGMPS
FDA
GXP
MAINTENANCE
PROBLEM SOLVING
Additional Skills:
QA
SYSTEM VALIDATION
CGMP
Additional Information: MUST HAVES:
• Experience with Veeva Systems preferred
• Excellent interpersonal skills with the ability to influence individual and teams across the organization
• Strong in Critical Thinking / Problem Solving with the ability to evaluate quality matters and make decisions utilizing risk-based
approach
• Must be flexibility/Adaptable with strong attention to detail
NICE TO HAVES:
• Vendor Management experience
• Risk based approach to validation
• Leading enterprise-wide system implementation