Plant Quality Assurance
Desired Skills: QA,GMP,Audit,Quality Assurance,plant QA
PE Global are currently recruiting for a Senior Plant Quality Assurance, for a BioPharma client site in South Dublin
12 month initial contract, with potential extension.
This is a hybrid role, the preference here is for local candidates or candidates within a commutable distance to the site, as the team acts as a support function. Should something happen onsite the candidate will need to respond and be there.This doesn’t happen frequently, but that flexibility and ability is required.
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.
Responsibilities include but are not limited to:
- 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 company 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 company safety standards and SOPs
- In line with business requirements, these responsibilities may expand or otherwise include additional areas of responsibility which are not described in this specification but are associated with the role
Qualifications & Experience:
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.
Interested candidates should submit an updated CV.
Please click the link below to apply, call Chloe on 086 0200448 or alternatively send an up-to-date CV to chloe.slingsby@peglobal.net
***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***