Do you want to join a progressive company with state of the art working facilities, which include an onsite gym and flexible working conditions such as flex hours and WFH?
If the answer is yes, we have an opening available for a Senior QA Specialist for Automation Support. This is a Senior position within the QA function which will generally report to a QA Senior Manager. In this role you will be part of a team who provide technical QA support to a range of Automation & IS projects on site.
 
Why you should apply:

• This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
• There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives.
• Our client is developing the capability to produce all its medicines in Dublin, helping to ensure continuity of supply of our medicines as they expand internationally.

 
What you will be doing:

• Managing Quality oversight of processes and procedures related to IS, CS & Automation compliance (ex: BMS, PCS, FMS, HMI upgrades etc.)
• Reviewing Quality and approving of C&Q documentation
• Perform all activities in compliance with safety standards and SOPs
• Ensuring adherence to required policies and procedures.
• Working cross functionally.
• Supporting a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations.
• Providing 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.
• May include additional areas of responsibility

• Bachelors’ degree in Science or an Engineering related discipline is preferred.
• 7+ years of relevant experience working in the pharmaceutical or biotechnology industry as a Subject Matter Expert providing quality direction of introduction of significant project such as new Fill line / Isolator
• Self-motivated
• Critical thinking skills.
• Great organisational, communication, coordination, and meeting facilitation skills.
• Ability 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.