Senior Qualification Validation Specialist (Pharma/Biotech)

Responsibilities:

• Provide Quality oversight to Manufacturing process equipment validation / qualification / replacement & future connectivity projects

• Review and approve acceptance test/reports in accordance with relevant policies, standards, procedures and guidelines timely

• Review and approve as needed, qualification/validation engineering changes, exceptions, deviation and/or investigations encountered during acceptance test execution representing Quality.

• Collaborate with multi functions to arrange, plan and ensure smooth running of the execution activities.

• Any other tasks as and when assigned by the supervisor.

• Support other technical changes and duties as required.

About You:

• Degree or higher in Science or Engineering or Pharmacy discipline

• Possess minimum 5 years of qualification/validation experience.

• Good leadership and communication skills.

• Mentoring and coaching skills.

• Excellent team player willing to work for the common goal.

• Knowledge of pharmaceutical regulatory requirements (GMP) is essential.

• Must become familiar quickly with products and processes in order to assess quality issues.

• Shows a high level of tenacity to ensure closure of issues.

• Largely self-managed with ability to communicate upwards and cross functionally to ensure all key project milestones are met.

  Duration: 12 Months