Senior QA Specialist

3 weeks ago

Dublin, Ireland PE Global Full time

The role: PE Global is currently recruiting for a Senior QA Specialist on behalf of a leading pharmaceutical company based in Dublin North. This is an initial 12 month contract role. Description: Key QMS experience is essential, ranging from exposure to CAPAs, de Support key stakeholders during the preparation and management of audits/inspections. Support the development of the schedule / plan and its communication. Lead the creation of audit agendas by adequate identification of risks/issues and engagement with stakeholders to develop the audit. Review and approval of audit reports and issuance. Input data/feedback from report/response entry into the Quality Management system and tools. Lead the review of audit actions from receipt to closure. Support quality system metrics review and reporting. Support the team during audits and inspections, by taking on activities to support inspection/audit readiness. Lead audit consultancy communications in the management of the audit program. Ability to work independently and within a team as an individual contributor. Partner with key stakeholders in the collection of key feedback to enable the audit function to operate effectively. Acts as a quality point of contact for audit/inspection queries from stakeholders. Participate and lead continuous compliance improvement projects within the team. Deliver Quality Assurance review and approval of SOPs and procedural documentation. Act as SME / Quality contact on key Quality system records, including audits, inspections, deviations, change controls. Support audit conduct, when required. Education and Experience: Minimum of 5 years experience in a GxP Quality Assurance or Compliance Management related role, with Quality Management Systems knowledge. -Clear understanding of the audit lifecycle, from planning, conduct to closure. Demonstrable communication and project management skills; experience working in cross-functional teams. Strong Business Partner with a focus on collaboration and delivering results. Knowledge of applicable international GXP regulations and standards (e.g., GMP, GDP etc.). Excellent interpersonal skills are required, as is the ability to communicate well, both verbally and written. Experience with Quality Systems/tools (e.g. Microsoft office, ECMS, EQV, SmartSheet) an advantage. Interested candidates should submit an updated CV. Please click the link below to apply, call Kellie on or alternatively send an up to date CV to ***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland*** Although it is not possible for us to respond to all applications, we at PE Global will do our upmost to give you feedback on your application. You have sent your Cv into us as a company and even though you have sent your CV to a particular position, we are making the reasonable assumption that you are active on the job market and as part of our normal recruitment service we will discuss other suitable positions with you. You are free to opt out of this so please specify in your application to us if you just want to be contacted in relation to a specific vacancy. Your Cv is sent to a central recruitment inbox which a number of people in the applicable PE Global division have access to and so this means that you might not be contacted by the named person in this advert. Skills: quality assurance audits GMP quality systems

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