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 subject
* matter 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 as
* required
* 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
***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland****