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Sr. Computer Systems Validation

1 month ago

Norwich, United States Career Developers Full time

Refer a friend: Referral fee program Career Developers Inc , a well-established staffing agency/consulting firm, is celebrating 30 years in business. Previously in Ramsey, NJ for 25 years and now headquartered in sunny West Palm Beach, FL, we offer comprehensive commercial and government staffing services nationwide (GSA Contract holder). With a portfolio of carefully chosen clients to represent, we ensure a productive partnership that exceeds most others. Our commitment and goal for our candidates lie in efficiently managing your expectations through business intelligence, spending time for interview preparations, providing open communication, and delivering exceptional feedback throughout the process. We look forward to helping advance your career Sr. Computer Systems Validation (CSV) Specialist - (Sr. Manager Level) Location: Norwich, NY – Must live locally or be able to move to the area independently. Salary: 145-155K + Bonus SUMMARY OF POSITION The CSV Sr. Manager is responsible for planning, writing, implementing, and reviewing computer system validation protocols of GxP computerized systems. Evaluate, propose, and implement technology solutions that improve digitization, compliance, and productivity. Serve as the CSV subject matter expert and guide and interpretation of GxP guidance and regulations of computerized systems, electronic records/signatures, and data integrity requirements. Collaborate with peers across Alvogen on quality, data integrity, and Computer system validation procedures. ORGANIZATION STRUCTURE The CSV Sr. Manager reports to the VP of IT. There will be no direct reports. RESPONSIBILITIES Draft validation plans, installation qualifications (IQ), operational qualifications (OQ), performance qualifications (PQ), and final validation reports. Review and approve other CSV-related deliverables, such as User Requirements (URS), Functional Specifications (FS), and Design Specifications (DS). Lead the resolution of any data integrity or critical quality issues related to IT Quality Management. Involved in continuously improving IT quality management systems and computer systems validation. Manage (where applicable) outside vendors to complete the required validation activities. Support project teams in the review and QA approval of system validation by FDA guidelines. Contribute expertise and provide guidance on 21 CFR Part 11, GAMP5, and EU GMP Annex 11 requirements and data integrity principles and requirements. Leadership: Establish necessary policies and procedures regarding SAP management. Periodically review policies and procedures for compliance and supply the necessary information for SOX/IT audits. Lead the SAP Security Administrator in establishing procedures for security management. Site SAP lead for large NPI projects that involve production, plant maintenance, and quality management. Establish working relationships and leadership to contractors and consultants for large system rollouts. Lead for QUMAS SAP documentation structures and use. SAP Maintenance & GxP: Generate system documentation for configuration or development associated with GxP processes. Review SAP Audit trails. Contribute to the Global Validation team for system validation documentation, including validation plans, protocols, reports, and risk assessments. Maintain continuity on validation documentation for original implementations and new sites rolling on. QUALIFICATIONS At least 8 years experience with validation of computerized systems, specific expertise in ERP and Laboratory systems highly preferred. Minimum 6 years experience in working with quality systems and the GMP environment of pharmaceutical manufacturing. The desired attributes are attention to detail, thoroughness, and willingness to learn. Good communication skills. Manufacturing industry experience with a good understanding of business processes and information flow throughout the business. Strong knowledge of ERP fundamentals. Ability to assist users in solving systems problems. Ability to read and interpret technical manuals used in the implementation of a new organization unit. Ability to maintain records, write reports and create presentations. Excellent organizational skills. Self-starter and a team player. Minimum travel. GMP DECISION-MAKING AUTHORITY Approves GMP documentation related to computerized systems or computerized system components. #J-18808-Ljbffr