QA Technical Support Specialist

QA Technical Support Specialist - Remote
RK5149
Contract 12 months
Dublin


We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.





Key Responsibilities:

• Accountable for Quality oversight of processes and procedures related to Packaging, inspection Process Development, Validation, Engineering, Facilities/Utilities.
• Quality review and approval of Validation and qualification documentation and SOPs to support site validation activities:

• Review of DS & QRAES documents
• Review of validation Plans, Protocols, IOQ, PQ and associated validation documents
• Review of executed validation documents and reports

• Perform all activities in compliance with safety standards and SOPs
• Be involved in all Validation Cross Functional Teams (CFTs) at the site to ensure adherence to required policies and procedures.
• 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.

• University degree. Science or Engineering related discipline preferred.
• Relevant experience (7 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.