The role:
PE Global is currently recruiting for a QA Specialist on behalf of a leading pharmaceutical company based in Dublin North.
This is an initial 12 month contract role.
Overview:
Reporting to the Senior Manager QA Laboratory Operations, the QA Senior Specialist will support the development and implementation of the QA activities related to QC laboratory operations and QC site operations.
The role will support the centralized EU based Global Biologics Laboratory performing commercial finished product testing and release activities.
The QA Senior Specialist will also provide quality oversight for internal equipment qualification, method transfer activities, and QC site operations for the manufacture of biologics drug substance.
Responsibilities:
QA review and approval activities for:
Laboratory investigations and deviations and associated corrective actions.
Contract testing laboratories investigations and associated documentation
Operational SOPs, test methods, forms and directives
Annual product reviews
Trending reports
Laboratory equipment/instrument qualification protocols and reports
Protocols and reports for method validations and technical transfers
Change controls
Establishing best practices and continuous improvement initiatives, in collaboration with Quality Systems and Compliance, to ensure compliance of all QC activities to all applicable policies, directives, guidance documents and regulatory requirements.
Supporting the QC laboratory through global regulatory agency inspections and achievement of market approvals.
Supporting the execution of the internal audit program.
Supporting QC and QA Network Harmonisation initiatives.
Education & Experience:
Minimum of a BSc in Science or related discipline
Minimum of 3 years Quality experience in the biopharmaceutical industry
A thorough understanding of cGMP requirements for laboratory compliance including equipment and instrumentation qualification requirements is essential.
Excellent written and verbal communication skills
Ability to work on his/her own initiative in addition to working as part of a team
Ability to work across a team matrix in order to meet accelerated timelines
Excellent time management & organisational skills along with a proven ability to multi-task
Interested candidates should submit an updated CV.
***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***
Please click the link below to apply, call Kellie on ********** or alternatively send an up to date CV to ******
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