Senior Validation Specialist

3 days ago

Singapore beBeeQuality Full time $80,000 - $120,000
Job Description

Pharmaceutical companies rely on experienced professionals to oversee the commissioning, qualification, and validation of equipment and systems. This role involves ensuring that all documentation meets regulatory guidelines, maintaining accurate records, and collaborating with quality control teams.

Key Responsibilities:
  • Documentation & Execution
    • Develop and review Commissioning and Qualification (C&Q) documents, including qualification plans, protocols, and data integrity assessments.
    • Maintain accurate records of test execution and deviations.
  • Equipment & Systems Qualification
    • Collaborate with quality control experts to capture and align user requirements for the qualification of new laboratory and production equipment.
    • Participate in risk assessments and define qualification strategies in alignment with project and regulatory requirements.
  • Vendor & Stakeholder Coordination
    • Liaise with equipment vendors and service providers to review and assess vendor-supplied documentation.
    • Coordinate execution of vendor IOQs and support resolution of technical or compliance issues.
  • Compliance & Continuous Improvement
    • Support deviation management, change control, and CAPA activities related to qualification and commissioning projects.
    • Contribute to continuous improvement initiatives to streamline CQV processes and enhance efficiency.
    Required Skills and Qualifications:
    • Education: Bachelor's degree in Engineering, Life Sciences, or a related field.
    • Experience: Experience in commissioning, qualification, and validation (CQV) in a regulated pharmaceutical/biopharma environment.
    • Knowledge: Familiarity with regulatory guidelines, such as FDA, EMA, ICH, ISPE, and GAMP 5.
    • Technical Skills: Strong technical writing, analytical, and problem-solving skills.
    • Soft Skills: Excellent coordination, communication, and stakeholder management abilities.
    Benefits:

As a valued member of our team, you will have opportunities for career growth, competitive wages, and travel. We strive to cultivate a positive work environment where empowerment, passion, and perseverance thrive.

Others:

We are an equal opportunity workplace, proud to celebrate diversity and promote inclusion.

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