Find external quality assurance jobs Jobs in cork, c

Operations Compliance Specialist (TEMPORARY)
BioMarin —Cork, County Cork
- Full-time
- Communication skills
EHS Advisor
B.M.D. & Company —Cork, County Cork
- Full-time
- Microsoft Powerpoint
- Microsoft Excel
- Microsoft Office
- Employee assistance program
Process / Plant Engineer
PepsiCo —Cork, County Cork
- Microsoft Powerpoint
- AutoCAD
- Microsoft Excel
Food Production Manager
Kepak Group —Watergrasshill, County Cork
- Full-time
- Food service
- Manufacturing
- Employee discount
- Referral programme
Quick apply
TSMS Laboratory Technician
Eurofins Ireland PSS —Kinsale, County Cork
- Full-time
- No degree
- Data entry
- Organisational skills
- Free parking
- Annual leave
Quick apply
Senior / Structural Engineer
Tetra Tech —Ballincollig, County Cork
- Hybrid work
- Continuous improvement
- Civil Engineering
Audit Technical Lead
Xeinadin —Cork, County Cork
- Analysis skills
- Communication skills
- Annual leave
- Employee assistance program
External Manufacturing Supply Manager
GE HEALTHCARE —Cork, County Cork
- Engineering
- ERP systems
- Project management
Engineering Lead
Abbott Laboratories —Cork, County Cork
- Full-time
- Engineering
- Project management
- Bachelor's degree
6d
Project Manager
BMD & Co Limited —Cork, County Cork
- Full-time
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
- Employee assistance program
Quick apply
Associate Engineer - Building Structures
Tetra Tech —Cork, County Cork
- Hybrid work
- Continuous improvement
- Civil Engineering
Project Manager
B.M.D. & Company —Cork, County Cork
- Full-time
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
- Employee assistance program
Data Architect
Everseen —Cork, County Cork
- Full-time
- Hybrid work
- Azure
- SQL
- AWS
Senior Bridge Engineer - Transport
Tetra Tech —Ballincollig, County Cork
- Hybrid work
- Master's degree
- Project management
- Contracts
Senior Civil Engineer
Ayesa —Cork, County Cork
- Full-time
- Hybrid work
- Project management
- Bachelor's degree
- Leadership
- Annual leave
- Employee assistance program
Quick apply
Principal Electrical Engineer - Substations (ROI)
AECOM —Cork, County Cork
- Full-time
- Hybrid work
- Project management
- No degree
- Electrical Engineering

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Operations Compliance Specialist (TEMPORARY)

BioMarin -
Cork, County Cork

Apply Now

Job details

Full-time | Temporary

Qualifications

Packaging
Data analytics
Technical writing
Data visualisation
Communication skills

Full job description

Who We Are

BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health.

Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities.

Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best – people with the right technical expertise and a relentless drive to solve real problems – and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we’ve produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options.

About Technical Operations

BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients.

Title: Operations Compliance Specialist

Work Type: Contract 12 Months

Manufacturing BioMarin International Ltd.

The Role: Reporting to the Inspection Readiness Lead, the Operations Compliance Specialist is responsible for all aspects of Documentation Management & Compliance including but not limited to the following main areas of responsibility of this role, which are as follows:

Document Management

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.

Compliance Tasks

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.

Additional tasks:

Collaborating with Global colleagues (as required) including but not limited to: Supplier Change Notifications, EDMS & Managerial Data Management
Management of Job Descriptions & New Hire Checklist and Assigning Lockers.
Be proactive & collaborative in troubleshooting & resolving issues with documentation,
training & systems collaborating with different departments across the site.
Engage in Continuous Improvement Initiatives
Manage compliance projects and Inspection readiness updates.
Apply aligned Operations Compliance Specialist role skills across Drug Substance, Drug Product and Packaging.

Requirements

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

Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.

Equal Opportunity Employer/Veterans/Disabled

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Apply Now

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external quality assurance jobs jobs in cork, c

Operations Compliance Specialist (TEMPORARY)

EHS Advisor

Process / Plant Engineer

Food Production Manager

TSMS Laboratory Technician

Senior / Structural Engineer

Audit Technical Lead

External Manufacturing Supply Manager

Engineering Lead

Project Manager

Associate Engineer - Building Structures

Project Manager

Data Architect

Senior Bridge Engineer - Transport

Senior Civil Engineer

Principal Electrical Engineer - Substations (ROI)

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