Recruitment Manager - Contracts at PE Global
PE Global are currently recruiting for a SR QA Specialist - Plant Technical Quality Assurance role, for our Bio client site based in South Dublin.
12 month initial contract, hybrid role
Senior Quality Assurance Professional – Plant Technical Quality Assurance (PTQA) Job Description
Key Responsibilities
* Act as Quality point of contact and decision maker during New Product Introductions, Technology Transfer and Process Validation activities for Aseptic products, ensuring all activities meet client and regulatory expectations.
* Quality review and approval of Process Development and Validation documentation
o Technical transfer documents
o 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; ensure scope of record is clear and implementation activities are robust and timely.
* Perform all activities in compliance with safety standards and SOPs.
* In line with business requirements, these responsibilities may expand or otherwise include additional areas of responsibility not described in this specification but are associated with the role.
Preferred Qualifications
* 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 (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, organised, 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.
Application Details
To apply, please call Audrey on 0214297900 or alternatively send an up‑to‑date CV to audrey.mccarthy@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***
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