The Role
PE Global are recruiting for an Operations Compliance Specialist for our biotechnology client based in Ringaskiddy Co. Cork. This is an initial 12-month contract role. Hybrid working options.
Job Responsibilities
Manage the authoring & drafting of all types of Manufacturing Operations documentation.
Specifications & associated forms in conjunction with the various departmental subjectmatter experts (SME)
Support document updates and manage timelines for cross functional Projects.
Act as a SME/Superuser on the Controlled Document System to facilitate the processing & approval of documents.
Organise & Facilitate Document Round Table meetings with cross functional teams asrequired
Mange and build Quality Veeva QMS metrics for Manufacturing Operations
Coach & Train colleagues in Documentation System & GDP queries
Support manufacturing operations on meeting deadlines on Veeva QMS records
Update compliance procedures and processes.
Generate Reports/Metrics & analyze trends as required including but not limited to:Veeva QMS reports, Doc Tracker Lookaheads, ASI/AIC metrics, Logbook Metrics,Doc Tracker Metrics, RFT Metrics.
Perform Logbook Training, review, and trending of all closed logbooks, identifying issues and managing timely archiving.
Train and perform Area Self Inspections & Generate ASI schedule.
Train Manufacturing colleagues in GDP/GMP
Management of Veeva paper Binders
Continuous monitoring of Compliance in Manufacturing.
Facilitate all internal and external Inspections.
Participate in permanent inspection readiness by completing Inspection walkthroughs within manufacturing operations.
Education & Experience
2+ years’ experience in technical writing and compliance
Proficient in data analytics, data visualization
Working knowledge in Regulations, GMP, GDP
2+ working within a regulated healthcare industry including a role in capacity of quality and compliance.
Strong verbal, written and oral communication skills.
Able to work independently and be flexible to changing priorities
Interested candidates should submit an updated CV.
Please click the link below to apply, or alternatively send an up-to-date CV to aisling.oleary@peglobal.net
***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland****
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