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Angela McCauley
Life Science

+353 87 696 0951
[email protected]
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Details

QA Specialist - Validation and NPI


Reference:AMC22404 Location: Carlow
Qualification:DegreeExperience:See description
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: QA Specialist

QA Validation Specialist (New Product Introduction)
11 month contract
On site Carlow
AMC22404

I am on the lookout for a QA Specialist for Validation and NPI for a rapidly expanding biotechnology manufacturer in Carlow. You will be an essential member of the Technical transfer and Validation team responsible for managing development and manufacturer of vaccines and biological products.

Alongside your day-to-day QA activities, your main focuses will be reviewing and approving all Validation documents relating to a sterile facility including cleaning validation ensuring to support corporate compliance and regulatory expectations for manufacturing.

You will need:

  • At least 3-5 years experience in a Quality role in pharmaceutical manufacturing in the EU
  • Bachelors degree in Science
  • Familiarity with sterile filling processes and equipment
  • Equipment and process validation experience.


Responsibilities:
  • Provide quality oversight and direction for the introduction of new products.
  • Serve as the point of contact for quality at both the site level and with external inputs, coordinating and attending Quality working group meetings.
  • Participate as a functional expert in the cross-functional team responsible for introducing products at Carlow.
  • Conduct quality reviews and approvals of engineering/validation/automation/utilities commissioning and qualification activities.
  • Author, review, and approve protocols and reports for technology transfer, method qualification, and method validation.
  • Review documentation associated with new product, such as, QC Test Specifications, BOMs, and MES documentation.
  • Support deviation close out in a timely manner.
  • Facilitate compliance direction for the site by adhering to divisional policies, guidelines, and regulatory requirements. Proactively evaluate site compliance against emerging trends and initiate major compliance initiatives for improved status and operational efficiency. Actively participate in Plant/Quality committees and collaborate with other site functional groups.

Requirements:
  • A Bachelor's degree or higher in a related Science discipline is preferred.
  • A minimum of 3-5 years of experience in a quality role, ideally in a pharmaceutical manufacturing environment.
  • Knowledge of regulatory/code requirements related to Irish, European, and International Codes, Standards, and Practices.
  • Familiarity with cGMP (current Good Manufacturing Practice) and GDP (Good Distribution Practice) is preferred.
  • Strong report, standards, and policy writing skills.
  • Experience with equipment and process validation.
  • Familiarity with sterile filling processes and equipment.
  • Experience or familiarity with Lean Six Sigma methodology is desired.


Apply today or get in touch with Angela McCauley at Life Science Recruitment for more information