Antaes Consulting SA | Validation Specialist
3 days ago
Job Responsibilities:
Contribute to Life Science projects for Antaes Asia clients
Manage change control processes for computer systems, ensuring accurate documentation, risk assessment, and approval workflow.
Coordinate with relevant departments to assess the impact of changes and ensure successful integration into existing systems.
Support Corrective and Preventive Actions (CAPA) for computer systems, conducting root cause analysis and implementing effective solutions.
Utilize and manage TrackWise for quality management processes, including deviations, CAPAs, and change control tracking.
Develop and configure TrackWise workflows and ensure proper documentation.
Develop and execute validation test scripts for Kneat to verify functionality, performance, and regulatory compliance.
Document test results, deviations, and corrective actions, and ensure alignment with validation protocols.
Contribute to the promotion of Antaes services on top of assistance provided to clients.
Job Requirements:
Bachelor’s degree in Computer Science, Life Science, or a related field
1-2 years of experience in validation of computer systems in the pharmaceutical industry
Proficiency in Kneat, TrackWise, CAPA, and change control processes.
Familiarity with industry regulations (e.g., FDA 21 CFR Part 11, GAMP 5).
Ensure compliance with 21 CFR Part 11 and other relevant data integrity regulations.
Strong documentation and technical writing skills.
Candidate must be highly motivated, able to work independently as well as in a team, and possess good organizational and oral and written communication skills.
Excellent communication skills, both written and verbal, in English.
Platform and Cloud Hosting Team Responsibilities:
Deploy, support, and maintain global Private Cloud infrastructure (compute, storage, software defined network, etc.)
Advise internal partners on how to leverage the Cloud – Private or Public – to increase the delivery of business value.
Guide and assist our application team to adopt our cloud-native technologies.
Work closely with regional and global teams to support on the platform.
Additional Responsibilities:
Install, configure, and support cloud platform underlying resource plane and control plane infrastructure (hardware and software components).
Release projects and maintenance operations in production without impact.
Be a technical reference for internal partners and advise on standard Cloud practices or innovative solutions to bring value to a competitive and challenging market environment.
Structure and guide our internal partners through their Cloud-Journey, accelerate the adoption of Cloud technologies and best practices, and provide consolidated reporting across the organization.
Create technical content such as reference apps, starter kits, and patterns and practical guidance that will get our developers excited about the potential of the Cloud.
Represent the team in various regional and global forums where technical expertise is required.
Be a technical reference and mentor for the team to increase their knowledge about software development & cloud patterns.
Coordinate activities and processes required for effective day-to-day organization of IT Infrastructure assets and contracts management.
Manage resource onboarding/offboarding/contract extension and headcount tracking and reporting including PPM Management and reporting.
Asset Management Responsibilities:
Develop and maintain frameworks, RACI, and end-to-end process/engagement model for onboarding IT Assets in the region (reconciling with financial books).
Assist with the governance of asset inventory including stock take and checks.
Conduct periodic internal quality assurance assessments across the IT Asset portfolio, highlighting any potential gaps, defining a remediation plan, and ensuring continued adherence to Group IT Asset Management standards.
Contract Management Responsibilities:
Ensure all contracts are registered in SourcingHub and aligned to Marley Asset Inventory.
Ensure adherence to contracts and sourcing requirements of existing vendor services.
Escalate appropriately to ensure Department Accountable Ex-Co are informed and necessary remediation implemented.
Assist with designing processes to streamline and maintain an accurate BAU contracts management schedule.
Business Management / PMO Responsibilities:
Publish reports of CTB/RTB consumption from Pyramid and follow-ups.
Assist with producing TCO reporting (on Apptio).
Work with Procurement and Expense team on follow-ups and maintain governance.
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