Quality Assurance Specialist

Hobson Prior are currently seeking for a Quality Assurance Specialist to join a fantastic pharmaceutical organisation on a permanent basis located in Shannon. Our client is focused in developing treatments that might have the possibility of being a cure for those who suffer from severe illnesses.

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities:

• For this position, you will offer QA evaluation for the eQMS system documents.
• Assist with management as well as instigating and assisting with consistent improvements of the quality management system.
• You will distribute GxP compliance training to operational areas.
• Produce and prepare quality documents such as SOP's, and controlled documents such as SOPs and Training Materials.
• Conduct external audits of crucial providers and service suppliers when needed.
• Guarantee compliant and adequate systems are in place to observe investigations, CAPAs, audits and Quality Review Boards.
• Assist with preparing, implementing and following up on regulatory inspections.
• Any other assigned duties.

Key Skills:

• Interpersonal abilities.
• A high attention to detail.
• Works well with others as well as independently.
• Communication skills both verbally and in writing.
• Possesses a positive mindset with the ability to be flexible and adapts to business needs.
• An organised individual with the ability to manage time efficiently.
• Capable of escalating concerns to management and prioritising workload.

Requirements:

• Familiarity with working in a GxP setting which involves at least 5 years of experience in compliance and quality assurance.
• Computer literacy.
• At least 10 years of experience working within a GMP regulated setting, biotech or similar manufacturing environment would be ideal.
• Acquaintance within operating and improving all aspects of a local QMS, which involves investigations, change controls and CAPAs.
• Prior involvement in conducting both internal and/or external audits.
• Familiarity in managing competent authority, regulatory body inspections and audits.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.