Job Description
PE Global is currently recruiting for a Software Quality Assurance Engineer for our biopharmaceutical client in Dublin. This is an initial 12-month contract, hybrid role.
Key Responsibilities
• Accountable for Quality oversight of processes and procedures related to IS, CS & Automation compliance (ex: BMS, PCS, FMS, HMI upgrades etc..)
• Quality review and approval of C & Q documentation
o Review of Risk Assessments, DS, URS & QRAES documents
o Review of validation Plans, Protocols, IQ, OQ, PQ and associated validation documents
o Review of executed validation documents and reports
• Perform all activities in compliance with safety standards and SOPs
• Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations.
• 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.
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
Preferred Qualifications
• University degree. Science or Engineering related discipline preferred.
• Relevant experience (5 yrs +) working in the pharmaceutical or biotechnology industry as a Subject Matter Expert providing quality direction of introduction of automation / IS projects
• 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 Paul Wheatley on 083 094 0199 or alternatively send an up-to-date CV to paul.wheatley@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***