Application Specialist CSV/SDLC

Application Specilaist CSV/SLDC 

Brief Position Description: 

As part of Novotech ITC department, the Software Development Lifecycle (SDLC) and Computer System Validation (CSV) Specialist is responsible for leading GxP validation and software testing strategies across GxP applications and support systems to guide all system and process owners on UAT planning and execution. 

Education and Experience:

• Degree in a science or information technology related discipline with a minimum of 5 years of relevant experience in SDLC and CSV projects. 
• Experience or background in highly regulated industries such, healthcare, pharma, or biotech industry is desirable. 

Skills and Competence:

• End to end understanding of regulatory guidelines including understanding of risk-based validation approach.
• Strong working knowledge of 21 CFR Part 11, Anenxure-11, Validation, SDLC and Change Management processes.
• 3-5 years of experience in IT SDLC, quality assurance, or system validation roles.
• Audit experience on IT systems (GxP and Non GxP).
• SOP and template authoring experience.
• Experience in executing IT projects using different methodologies (i.e., waterfall, agile etc.)

Responsibilities:

• The CSV Specialist acts as primary point of contact for all validation aspects of GxP applications and works with system owners, Clinical Systems team, QA team, Business Operation teams to maintain CSV compliance. 
• The CSV Specialist will define validation/testing roadmap for GxP applications and systems, including risk assessment planning, execution, and authoring validation documents. Strategize and plan UAT testing along with application team leads/SME’s.
• Author and review SDLC/CSV documentation such as Validation/Test plan, User Requirement Specifications, Process Flows, Design Specifications, Requirement Traceability Matrix, Test Cases, Test Scenarios, etc.
• In consultation with key stakeholders for relevant GxP projects, prepare time and resource estimates for project deliverables related to SDLC/UAT testing.
• Review/publish system test reports, defect summary report, perform defect analysis and drive defect to closure.
• Authoring/reviewing IT Periodic evaluation reports with respect to GxP systems, user setup and configuration management. 
• Liaise with respective teams regarding change management activities associated with IT applications and actively participates in Change Approval Board (CAB) meetings.
• Identify and report any quality or compliance concerns and take immediate corrective action as required.
• Assist in Quality Investigations, vendor audits, system audits and CAPA preparation. 
• Guide system owners, Process owners and System administrators on the impact of changes and ensure change controls and best practices are followed.
• Understand company processes in areas relevant to SDLC and CSV and be quality minded in performance of duties. 
• Maintain complete and compliant documentation throughout the system lifecycle.
• Review and approve technical and operational documentation including requirements, design specifications, test scripts, SOPs, and work instructions.
• Support internal and external audits, remediation activities, and continuous improvement initiatives.

Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect. Our team members are passionate about what we do, but we understand work is only one of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs. We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities. We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to talking to you about working at Novotech.

Responsibilities:

• The CSV Specialist acts as primary point of contact for all validation aspects of GxP applications and works with system owners, Clinical Systems team, QA team, Business Operation teams to maintain CSV compliance. 

• The CSV Specialist will define validation/testing roadmap for GxP applications and systems, including risk assessment planning, execution, and authoring validation documents. Strategize and plan UAT testing along with application team leads/SME’s.

• Author and review SDLC/CSV documentation such as Validation/Test plan, User Requirement Specifications, Process Flows, Design Specifications, Requirement Traceability Matrix, Test Cases, Test Scenarios, etc.

• In consultation with key stakeholders for relevant GxP projects, prepare time and resource estimates for project deliverables related to SDLC/UAT testing.

• Review/publish system test reports, defect summary report, perform defect analysis and drive defect to closure.

• Authoring/reviewing IT Periodic evaluation reports with respect to GxP systems, user setup and configuration management. 

• Liaise with respective teams regarding change management activities associated with IT applications and actively participates in Change Approval Board (CAB) meetings.

• Identify and report any quality or compliance concerns and take immediate corrective action as required.

• Assist in Quality Investigations, vendor audits, system audits and CAPA preparation. 

• Guide system owners, Process owners and System administrators on the impact of changes and ensure change controls and best practices are followed.

• Understand company processes in areas relevant to SDLC and CSV and be quality minded in performance of duties. 

• Maintain complete and compliant documentation throughout the system lifecycle.

• Review and approve technical and operational documentation including requirements, design specifications, test scripts, SOPs, and work instructions.

• Support internal and external audits, remediation activities, and continuous improvement initiatives.

• End to end understanding of regulatory guidelines including understanding of risk-based validation approach.

• Strong working knowledge of 21 CFR Part 11, Anenxure-11, Validation, SDLC and Change Management processes.

• 3-5 years of experience in IT SDLC, quality assurance, or system validation roles.

• Audit experience on IT systems (GxP and Non GxP).

• SOP and template authoring experience.

• Experience in executing IT projects using different methodologies (i.e., waterfall, agile etc.)