Laboratory Validation Specialist

2 weeks ago

Galway, Galway, Ireland beBeeValidation Full time €72,000 - €84,000
Job Description

We are seeking a highly skilled Laboratory Validation Specialist to join our team at our Westport facility on an initial six-month contract. As a key member of the Quality Control department, you will be responsible for qualifying and validating laboratory equipment, systems, and processes used in routine operations.

The successful candidate will oversee site validation master plans under prospective, concurrent, and retrospective validation studies in a timely manner with relevant engineers. You will work on validation projects as the departmental point person, completing associated project documentation according to current corporate and regulatory expectations.

You will participate in risk assessment processes for all business units and design review processes for all business units. Additionally, you will track and generate weekly metrics (GTW QMS, EHS, Compliance Wire etc.).

Facilitating PQR review processes, Regulatory Review Processes, and Laboratory Equipment Review Processes as per current rota's is also a critical component of this role. The ideal candidate will stay up-to-date with current and changing regulatory guidance for relevant areas of validation and provide support for audit preparation, direct audit interaction, and involvement in audit response.

In this dynamic environment, you will support internal EHS requirements, procedures, and policies, ensuring continued conformance to the EMS within the department.

Required Skills and Qualifications
  • Bachelor's degree required in a science-based or engineering discipline.
  • Experience in the Pharmaceutical industry.
  • Excellent project management skills.
  • Proficient in Microsoft Office suite of programs.
  • Critical thinking and problem-solving skills.
  • Ability to articulate clearly when dealing with internal and external bodies.
  • Excellent conflict handling skills.
  • Expertise in relevant subject matter areas such as Equipment, Facility, Aseptics, Process, CPV, CSV, Cleaning.
What We Offer

This is an excellent opportunity to join a forward-thinking organization and contribute to the success of our team. If you are a motivated and detail-oriented individual with a passion for laboratory validation, we encourage you to apply.

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