Validation Specialist

Roles and responsibilities

We are seeking an outstanding Validation Specialist to join us at MNT-Halan!

Key of Qualification

• Handle the Anti-Money Laundering and Counter-Terrorist Financing (AML/CTF) program in the company for both wallet and card.

• Manage the local and global trade sanctions screening program for all business internal customers.

• Handle all the screening cases within the agreed service level for both wallet and card.

• Review the KYC data and edit the data on portal if it doesn’t match with the ID & KYC.

• Handle all the tickets that are received from the retail to avoid any delay in the screening process.

• Daily rechecking on the customer base to provide smooth card activation process.

• Verify and review the rejected data after editing from the branches.
Regulatory Knowledge:

Thorough knowledge of industry regulations and standards such as FDA (Food and Drug Administration), EMA (European Medicines Agency), ISO 13485, GxP (Good Laboratory/Manufacturing/Clinical Practices), 21 CFR Part 11, and EU Annex 11 for software and system validation.
Familiarity with validation protocols and regulatory requirements specific to the pharmaceutical, biotech, medical device, or manufacturing sectors.
Validation Processes & Methodologies:

Experience in equipment validation, process validation, and computer system validation (CSV).
Proficient in developing and executing Validation Master Plans (VMP), protocols (IQ, OQ, PQ), and final validation reports.
Knowledge of the life cycle of validation, from project initiation to execution and post-validation monitoring.
Risk Assessment & Management:

Ability to conduct risk assessments to identify potential issues, mitigate risks, and prioritize validation activities based on impact and regulatory requirements.
Experience in Failure Mode Effects Analysis (FMEA) or other risk management methodologies for validating systems, equipment, and processes.
Quality Management & Compliance:

Strong understanding of quality management systems (QMS) and their integration into validation processes.
Ability to ensure compliance with GxP, FDA, EMA, and other local or international regulatory standards.
Familiarity with Audit processes and assisting with internal and external audits related to validation activities.

Desired candidate profile

• Documentation & Reporting:

  • Exceptional skills in preparing clear, detailed, and comprehensive validation documentation (validation protocols, reports, deviation investigations, corrective and preventive actions (CAPA)).
  • Proficient in documenting change control processes, maintaining records of validated systems, and ensuring all documents are audit-ready.
  • Knowledge of Document Management Systems (DMS) for tracking and managing validation documents.

• Problem-Solving & Troubleshooting:

  • Strong analytical and troubleshooting skills to investigate issues related to systems, equipment, and processes.
  • Ability to identify and address non-conformities or deviations during validation processes, and implement corrective actions or improvements.

• Technical Skills:

  • Experience with data logging and instrument calibration.
  • Familiarity with automated systems and software validation tools (e.g., LabVIEW, MasterControl, TrackWise).
  • Understanding of Good Automation Practices (GAP) and data integrity standards for system validation.

• Project Management:

  • Strong project management skills, including planning, scheduling, and tracking validation tasks.
  • Ability to coordinate with cross-functional teams (engineering, quality, regulatory, production) to ensure timely execution of validation projects.

• Communication & Interpersonal Skills:

  • Ability to effectively communicate complex technical information to both technical and non-technical stakeholders.
  • Collaborative and able to work as part of a team, providing support for various departments involved in the validation process.
  • Strong presentation and report-writing skills to present findings, status updates, and final validation reports to management or auditors.