QA Validation Lead

  • Location

  • Salary

  • Job Type

  • Functions

    Quality Assurance

The role –

As a QA CSQ/CQV Lead, you will play a pivotal role in ensuring the quality and compliance of validation and equipment qualification activities within a leading large molecule CDMO. This role involves overseeing computerised systems and lab equipment qualification, aligning with all relevant regulations, company policies, and contractual obligations. By reviewing and approving commissioning and qualification activities, you’ll contribute to the meticulous execution of validation lifecycle documents. Additionally, you will provide essential guidance for equipment lifecycle documentation, actively participate in investigations, review SOPs, deviations, and collaborate on customer audits and regulatory inspections.

Your Responsibilities –

  • Oversee validation and equipment qualification activities, ensuring compliance with regulations and obligations.
  • Review and approve commissioning and qualification activities, encompassing the validation lifecycle process.
  • Provide guidance for creating equipment lifecycle documentation, including protocols, assessments, and technical specifications.
  • Participate or lead investigations related to qualification discrepancies.
  • Review and approve SOPs, deviations, and other key quality documents.
  • Participate in customer audits and regulatory inspections.
  • Collaborate with internal and external stakeholders to ensure effective communication.
  • Align with company’s quality strategy and contribute to continuous improvement.
  • Fulfil additional tasks as directed by the QA department management.

Your Profile –

The ideal candidate for this position will have the following:

  • Minimum of a bachelor’s degree in biology, biotechnology, or a relevant discipline.
  • A minimum of 5 years of QA experience in the Biotechnology or Pharmaceutical industry.
  • Strong understanding of GMP regulations.
  • Excellent knowledge of validation principles and industry best practices.
  • Familiarity with audit challenges and regulatory inspections.

Next Steps –

If you think that you are up for the challenge, then click ‘Apply Now’ or send a copy of your CV to arrange a private and confidential conversation. Looking forward to speaking with you!

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