Pharmaceutical Quality Assurance Specialist

1 day ago


Singapore RECRUIT EXPRESS PTE LTD Full time
Job Title: Pharmaceutical Quality Assurance Specialist

$120,000 - $180,000 per annum

Company Overview

At RECRUIT EXPRESS PTE LTD, we strive to provide top-notch recruitment services that cater to the diverse needs of our clients. Our team of experts is dedicated to delivering exceptional results and building long-lasting relationships with our candidates.

Job Description
  • Support site projects related to Qualification/Validation to ensure compliance with internal and regulatory requirements.
  • Review and approve Quality Control documents (protocols, reports, procedures) for adherence to industry standards.
  • Evaluate and approve discrepancies in qualification/validation protocols, documenting incidents and corrective actions.
  • Act as Quality Representative in projects, focusing on Quality Systems and Validation.
  • Provide expertise and oversight in developing or modifying Analytical Instrument Qualification, Method Validation, and Reagent Qualification.
  • Ensure qualification/validation documents are clear and defendable during inspections.
  • Oversee Quality Control validation maintenance and the Master Validation Plan.
  • Support multisite initiatives for harmonization of Quality Systems and qualification/validation activities.
  • Foster strong partnerships with other departments to ensure effective communication and collaboration.
  • Adhere to EHS requirements and Shire's Code of Conduct.
Required Skills and Qualifications
  • Minimum degree in Biochemistry / Bioengineering or related science field of studies.
  • Prior Pharma/Biotech experience with a thorough understanding of FDA/EU cGMP validation requirements/expectations.
Benefits

RECRUIT EXPRESS PTE LTD offers a comprehensive compensation package, including a competitive salary, opportunities for professional growth, and a collaborative work environment.



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