Strategic Business Partner acting as a consultant in HR practices and people management. Supporting leadership in organizational structures and change initiatives for high performance teams.
About the role
- Validation Analyst III ensuring compliance of computerized systems at Altasciences. Involves validation processes, regulatory audits, and collaboration across departments.
Responsibilities
- Author, execute, monitor and/or review Validation documents such as: Risk Assessments, Validation Plans, Test Scripts (IQ/OQ/PQ), Traceability Matrix, and Validation Reports per Standard Operating Procedures (SOPs)
- Work closely with internally assigned departments and externally with software vendors and/or contractors, regulatory audit teams and other service providers to facilitate implementation, testing and application of validation principles throughout the implementation process
- Train interdepartmental teams on basic GDP compliance with respect to CSV practices
- Demonstrate mid-level technical expertise to define approaches and execution of system validation activities in accordance with cGMP, cGXP, CFR 21 Parts, 11, 210 and 211, EU Annex 11, ICH Q7, Q8 and Q9, and other applicable regulations, procedures and industry guidance
- Ensure adherence to change management procedures for validated systems
- Conduct technical assessments (e.g., Periodic Review) for validation compliance and impact
- As applicable, maintain inventories, lists, status, and other tracking tools of approved validation documentation, system configuration, and change control
- Possess and understand the key aspects of IT including: networking, LAN, WAN, Computers (servers and workstations) as well as several COTS software systems
- Contribute to the development and maintenance of the validation quality management system (e.g., Master Plan, CSV SOPs)
- Respond to internal/external audit findings and contribute to corrective actions as needed
- Participate in client audits and/or Quality Assurance Department activities during regulatory CSV internal/external audits
- Present and support the validation quality management system towards clients and agencies, as required
- Coordinates activities between ITOPS and Development to ensure CSV project delivery
- Can design, develop and implement workarounds to software or process compliance failures
- Understands laboratory workflows and adapts software as well as processes for GxP compliant operation for several pharmaceutical/CRO software systems
Requirements
- Bachelor's degree in IT, Science, or related field
- 5 years experience in computerized system validation in a regulated environment
- Knowledge of MS Office suite and software testing tools (Rational Visual test)
- Basic knowledge of software development SDLC design standards and standard testing
- Wide knowledge in COTS software systems used in Pharmaceutical/CRO industry with equivalent Laboratory process and systems knowledge
- English (written and spoken)
Benefits
- Health/Dental/Vision Insurance Plans
- 401(k)/RRSP with Employer Match
- Paid Vacation and Holidays
- Paid Sick and Bereavement Leave
- Employee Assistance & Telehealth Programs
- Telework when applicable
- Training & Development Programs
- Employee Referral Bonus Program
- Annual Performance Reviews
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Tech skills
Location requirements
Senior Analyst managing administrative and fiscal processes in a hybrid model at São Paulo. Ensuring quality, deadlines, and excellence in deliveries as a Key User in SAP.
Analista de Control de Marcas ensuring accurate financial reconciliation processes. Managing data analysis and incident reporting in hybrid operations.
Financial Analyst supporting financial planning and forecasting for Hewlett Packard Enterprise. Analyzing financial data, driving cross - business initiatives, and ensuring compliance with financial goals.
Financial Analyst responsible for leading financial planning and forecasting for NA CCOW. Collaborating with teams to optimize financial performance and support business decision - making.
Deal Desk Analyst supporting structuring, pricing, and terms of complex B2B SaaS transactions at Delinea. Collaborating with Sales and cross - functional teams to ensure deal execution efficiency.
Contribute to commercial planning and performance at Flash, a leader in HR solutions. Assist various teams with insights and reporting.
Analista Contábil managing financial and compliance routines at Vialaser. Responsible for financial statement preparation and external audit support.
Role overseeing the DWDM network operations for Vivo, focusing on failures analysis and process automation. Part of a team ensuring operational excellence for customer services.
Senior Analyst overseeing analytics and reporting for Comcast's Enterprise Real Estate team. Collaborating with various departments to create insights and data visualizations for senior leaders.