Biotech Plant Technical Quality Assurance

2 days ago

Dublin, Dublin City, Ireland JobContax Full time

Biotech Plant Technical Quality Assurance, Dun Laoghaire, Dublin

Office/Project Location:Dun Laoghaire, Dublin

Employment Type: Contract

Work Location:  Hybrid

Pay: €Neg per hour

Experience: 7+ years

Visa: EU passport or Stamp 4 visa required

Our client is a leading international Biotechnology company with a state of the art aseptic manufacturing facility in Dun Laoighaire, South Dublin. 

The plant is one of the most dynamic in Ireland and is currently undergoing rapid expansion and capital investment. 

This is an excellent opportunity to get experience into Ireland's leading aseptic manufacturing plant.

The Plant Technical Quality Assurance (PTQA) Specialist is a senior position within the QA function which will typically report to a QA Manager and will be required to be a Subject Matter Expert in their assigned area of responsibility.

Act as Quality point of contact and decision maker during New Product Introductions, Technology Transfer and Process Validation activities for Aseptic products, ensuring that all activities meet Amgen and regulatory expectations.

Quality review and approval of Process Development and Validation documentation

Technical transfer documents

Validation Protocols, executed validation documents and reports

Provide Quality direction and input at Change Control and Deviation Review Boards and assume QA oversight of change control and Deviation/CAPA records; ensuring scope of record is clear and implementation activities are robust and timely.

Perform all activities in compliance with safety standards and SOPs

Requirements

University degree. Science or Engineering related discipline preferred.

Understanding of principles of Validation and New Product Introduction

Experience in aseptic manufacturing

Relevant experience (7yrs +) working in the pharmaceutical or biotechnology industry as a Subject Matter Expert providing overall quality direction and oversight for key functional areas (i.e. Process Development, Validation, Manufacturing)

Experience in change control, non-conformance, corrective and preventative actions, and validation practices.

Ability to operate across functional boundaries, both internal and external.

Ability to work independently and remotely with minimum direct supervision.

Critical thinking skills.

Strong organisational, communication, coordination, and meeting facilitation skills.

Independent, self-motivated, organized, able to multi-task in project environments and skilled in communication and collaboration.

Team player prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making.

Package

Contract role - Hourly rate €50 - €57 per hour

Minimum 12 month contract

This is a hybrid role, so the preference here is for local candidates or candidates within a commutable distance to the site, as the team act as a support function.

So, something may happen, onsite and the CW will need to respond and be there. 

This doesn't happen frequently, but that flexibility and ability is required.

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