Maintenance Engineer

PE Global (UK); Cork; On-site; EUR 65,000 - 85,000; Full time

Job summary

A leading biotech company in Cork is seeking a Senior QA Specialist for a 12-month contract. The role involves oversight of Quality processes during product introductions and validations. Ideal candidates will have over 7 years of experience in the pharmaceutical or biotech sectors, with strong skills in critical thinking and communication. Apply with your updated CV to join this dynamic team.

Qualifications

• 7+ years of experience in pharmaceutical or biotechnology industry.
• Experience in aseptic manufacturing.
• Understanding of Validation and New Product Introduction principles.

Responsibilities

• Act as Quality point of contact during New Product Introductions.
• Review and approve Process Development and Validation documentation.
• Ensure compliance with safety standards and SOPs.

Skills

Quality point of contact

Critical thinking skills

Organisational skills

Communication skills

Team player

Education

University degree in Science or Engineering

Job description

Description

PE Global is currently recruiting for a Senior QA Specialist on behalf of a leading biotech company based in Dublin South. This is an initial 12-month contract role.

Overview

The Quality Assurance Technical Support (QA TS) 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.

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 that all activities meet 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
• 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

Education and 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 Kellie on 0214297900 or alternatively send an up to date CV to [e-mail]

Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland