ACCOUNTABILITY OBJECTIVE

This function is accountable for:

• coordination of validation activities in capital projects
• scheduling capital project activities related to Quality Systems and Engineering Systems
• point of contact validation coordination and planning

EDUCATION, TRAINING AND/OR EXPERIENCE

1. Degree

• Master degree

2. Formal education

• Scientific discipline (Engineering, Bio-engineering, Pharmacy, …)

3. Experience required

• Minimum of 3 years of experience in the pharmaceutical industry
• Knowledge of and experience in Validation
• Knowledge of and experience in Scheduling and MS Project
• Knowledge of and experience in Quality Management Systems
• Experience with at least one other Engineering System: Technology Management, Project Management, Good Engineering Practices, Testing and/or Contractor Management.

4. Specific training and skills

• Strong organizational skills and structured approach
• High level of social, communication and coaching skills
• Capable to maintain a good overview while diving into details when needed
• Knowledge of PC applications Word – Excel – Powerpoint – Sharepoint – MS Projects
• Fluent in Dutch and English

PRINCIPAL ACCOUNTABILITIES

Coordination of validation and planning activities

• Supports the project lead in coordinating the project team to achieve the defined project deliverables in relation to validation.
  • Composes and consolidates the overall validation project plan/report and clarifies the validation strategy to the project team, management and inspectors.
  • Continuously follows up the predefined validation strategy, adjusts and/or escalates if needed and provides overview of the status and potential impact on project timeline.
  • Coaches the project engineers related to validation and quality systems and watches over good validation practices and the quality of the different deliverables.
  • Facilitates and documents quality risk assessment activities.
  • Provides input for management communication & reporting.
  • Bridges between Engineering, Site Compliance, SME’s and System Owners.

• Supports the project lead in coordinating the project team to achieve the defined project time line.
  • Composes, consolidates and maintains the project schedule file in MS Project.
  • Monitors continuously the project schedule file and keeps the project team informed regarding the progress and alerts problems/conflicts relating to the execution of project tasks and activities.
  • Assists the project lead to define, evaluate and document project risks and mitigation plan.
• Provides input for management communication & reporting.

Supporting ownership of audit readiness program engineering

• Supporting role in the audit preparation of planned inspections
  • Communication
  • Preparation of the inspection tour (focus on construction zones and Engineering projects)
  • Follow-up construction area audit readiness
  • Follow up availability engineering spokes persons
  • Preparation pre requests inspections
• Post audit support
  • Support/coordination in defining audit responses and action plans
• Acts as back-up for the owner of the audit readiness program in engineering

Supporting process ownership of Quality and Engineering Systems

• Responsible for the initiation,  planning and execution of projects related to Quality Systems (Systems Validation, CRF, MIR, CAPA, …).
• Responsible for the initiation, planning and execution of projects related to Engineering Systems (Technology Management, Good Engineering Practices, Testing and Contractor Management).
• Acts as Engineering representative in process teams related to Quality Systems (change management, verification, validation, …).
• Investigation, documentation and follow-up of deviations (MIR) related to engineering projects
• Acts as back-up for the process owner Systems Validation.