CSV/CQV

Job Description:

• Contribute to Life Science projects for Antaes Asia clients.
• Work with cross functional team in providing Quality oversight in computerized system life cycle procedure and ensure compliance to GXP standards and company policies and procedures.
• Provide guidance and support to establish systems for ensuring Data integrity, compliance to CSV Plan and 21CFR Part 11.
• Act as one of the key focal points for CSV topics such as deviations, change management, investigations, CAPA identification and closure, and as a Subject Matter Expert.
• Generate, review and execute protocols / test case for initial validation programs related to GXP Computer systems. -e.g. Qualifications protocols - Software qualification, Input/Output loop verification, hardware qualification.
• Review and approve qualification documentations like URS, SLIA (system level impact assessment)/ CLIA (component level impact assessment), SRA (System Risk Assessment), DIRA/ DSA (Data security, audit trail review), DQ, SIOQ, HIOQ, FAT, FATSR, Traceability Matrix etc.
• Ensure adherence to CSV master plans and execution plans for GXP computer systems like DCS, PLC, BMS, MES, eBR, Lab Information systems, Environmental monitoring systems and other Business IT systems like Maximo, Network and ERP systems that are part of the GMP envelope.
• Any other tasks assigned.
• Contribute to the promotion of Antaes services on top of assistance provided to clients.

Job Description:

• Contribute to Life Science projects for Antaes Asia clients
• Develop and execute CQV documentation including commissioning protocols, FAT/SAT reports, IQ/OQ/PQ protocols, summary reports, and traceability matrices.
• End-to-end support for the CQV lifecycle for process, utility, and support systems—e.g., bioreactors, chromatography skids, filtration units, CIP/SIP, WFI, HVAC, autoclaves, and clean utilities.
• Participate in design reviews (URS, SDS, P&ID walkdowns) to ensure CQV considerations are integrated during project design and construction.
• Manage the execution of commissioning and qualification activities in line with project schedules, safety standards, and GMP compliance.
• Support automation qualification (DeltaV, PLC, SCADA) and ensure integration with process control systems.
• Review vendor documentation and coordinate FAT and SAT with suppliers and engineering teams.
• Troubleshoot and resolve technical issues encountered during CQV execution.
• Ensure all CQV deliverables meet internal Quality and Validation standards, and align with the site Validation Master Plan (VMP).
• Support the handover of qualified systems to Manufacturing and Maintenance teams, including training and documentation.
• Collaborate closely with cross-functional teams including Engineering, QA Validation, Manufacturing, and Automation.
• Contribute to the promotion of Antaes services on top of assistance provided to clients.

Direct Responsibilities

Requirement Gathering & Analysis

• Process Mapping: Map the "As-Is" workflow of bank guarantee issuance (from client request to SWIFT transmission) and design the "To-Be" optimized digital workflow.
• Stakeholder Management: Conduct workshops with Trade Finance Operations, Risk Management, and Legal teams to gather detailed functional requirements.
• Gap Analysis: Identify gaps between the current system capabilities and the business needs (e.g., inability to handle complex counter-guarantees).

Functional Design & Specification

• BRD/FRD Creation: Write detailed Business Requirement Documents (BRD) and Functional Requirement Documents (FRD).
• Workflow Logic: Define the logic for automated approvals, credit limit checks, and expiry notifications.
• SWIFT Integration: Define requirements for SWIFT MT760 (Issuance), MT767 (Amendment), and MT768 (Claim) messaging standards.
• Template Management: Design standardized digital templates for various guarantee types (Bid Bonds, Performance Bonds, Advance Payment Guarantees).
• Overall tracking and overseeing the solution delivery; including the traceability of the solutions, working with the scrum master in the sprints daily to facilitate and monitor the project delivery execution.
• Participate to project committees to communicate project delivery, risk management and record decisions and validation for implementation.

Testing & Quality Assurance

• UAT Coordination: Lead the User Acceptance Testing (UAT) phase, creating test scripts and scenarios that cover "happy paths" and "edge cases" (e.g., partial releases, overdue extensions).
• Bug Tracking: Document system defects and work with developers to prioritize fixes based on business impact.
• Data Migration: Oversee the mapping and migration of legacy guarantee data to new systems, ensuring no loss of expiry dates or liability amounts.
• Work with users on the test plan and responsible for end-to-end testing strategy and execution - To develop SIT/UAT/NRT scope and approach. To guide testing team inwriting test scenarios/cases and review to get signoff from stakeholders. To rationalize test cases when needed to match with available team bandwidth and target timeline.
• To validate SIT test results produced by testing team to signoff

Compliance & Risk Integration

• Regulatory Alignment: Ensure the system enforces ICC rules (URDG 758, UCP 600) and local central bank regulations.
• AML/Sanctions Logic: Work with the Compliance team to integrate automated screening triggers into the BG issuance workflow.
• Takes accountability of Trade Projects and drive the planning, responsible for the delivery from inception to implementation.
• Working closely with Product managers, Operation teams (both middle and back office) and IT (global/regional), business analysts to rationalize the scope and business case for the project proposal. Present the solutions for steering committee approval.
• Managing these approved initiatives, new business TACs/NACs and their interdependencies.  Working with the respective IT teams on the daily activities of the projects, and able to influence key stakeholders on decision making.
• Ensure Bank compliance policies and CIB ITO APAC standards/practices are strictly followed

Job Description:

• Contribute to Life Science projects for Antaes Asia clients
• Maintain and govern SAP Local Master Data, specifically focusing on critical pharmaceutical production elements, including Material Master, Bills of Material (BOM), Master Recipes, and Production Versions.
• Serve as the primary point of contact for troubleshooting and SAP support across key operational modules: PPDS (Production Planning and Detailed Scheduling), Process Order Execution, QM (Quality Management), MM (Materials Management), Warehouse (WM/EWM), SD (Sales & Distribution), and PM (Plant Maintenance).
• Monitor and support process order execution, ensuring that master data is correctly translating into seamless shop-floor operations and accurate warehouse movement
• Ensure all master data aligns with Good Manufacturing Practices (GMP) and global/regional Master Data Governance (MDG) standards. Participate in data cleansing, audits, and mass update initiatives.
• Work closely with cross-functional teams (Production, Quality, Engineering, and Logistics) across our manufacturing hubs to resolve data-related process bottlenecks and support regional system rollouts.
• Contribute to the promotion of Antaes services on top of assistance provided to clients

Job Description:

• Contribute to Life Science projects for Antaes Asia clients
• Lead complex technical investigations into manufacturing deviations, non-conformances, and environmental excursions.
• Utilize structured Root Cause Analysis (RCA) tools (e.g., Fishbone, 5 Whys, FMEA) to identify underlying triggers.
• Author comprehensive investigation reports that withstand rigorous internal and external regulatory audits (FDA,EMA, etc.).
• Perform impact assessments on product quality, safety, and efficacy.
• Design and implement Corrective and Preventive Actions (CAPAs) to eliminate recurrence of deviations.
• Monitor the effectiveness of implemented CAPAs through data-driven metrics.
• Identify trends in manufacturing data to proactively suggest process improvements and "Right First Time" (RFT) initiatives.
• Provide real-time engineering floor support to troubleshoot equipment malfunctions or process drift.
• Collaborate with Quality Assurance (QA) and Production teams to ensure all activities align with Standard Operating Procedures (SOPs).
• Participate in the drafting and revision of SOPs, Batch Records, and Validation protocols.
• Contribute to the promotion of Antaes services on top of assistance provided to clients