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

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Company Intel

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