Senior Qualification Validation Specialist

2 weeks ago


Tuas, Singapore NUSANTARA PRIME CONSULTING PTE LTD Full time

**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.
- Hands-on experience in the Validation life cycle of computerized systems is a plus.
- 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.

**Job Type**: Contract
Contract length: 12 months

Pay: $6,500.00 - $8,500.00 per month

**Experience**:

- qualification/validation: 5 years (preferred)
- biopharma, GMP, GDP: 5 years (preferred)
- CSV, CQV: 3 years (preferred)

Work Location: In person


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