Job Title
We are seeking a Senior Quality Systems Specialist to join our team.
Job Description
As a Senior Quality Systems Specialist, you will be responsible for the successful management and execution of all IS activities supporting Quality and Laboratory information systems. You will also lead the implementation of new Quality and Laboratory information systems and manage the associated team of reportees.
Responsibilities
* Manage IS aspects of Lab equipment including analytical equipment platform architecture, system ownership and lifecycle management
* Ensure that all Lab IT systems and Benchtop Analytical Equipment meet 21 CFR 11 and EU Annex 11 compliance requirements
* Lead and manage a team of QC System Specialists where applicable
* Provide effective communication and play a leading role in project management interaction with internal and external clients such as Quality Assurance, Regulatory Affairs, and QC analytical personnel
* Lead and support system improvements, development of detailed specification and standard operating procedures
* Ensure that all associated protocols/reports are completed, reviewed and approved within agreed timelines in order to secure reliable, consistent & compliant operation of all Lab Equipment/Instruments to meet the GMP and business requirements of the labs
* Lead technical root cause analysis, incident investigations and troubleshooting issues related to the Quality and Laboratory information systems
* Experience in change control, non-conformance, corrective and preventative actions, and validation practices
* Support new technology introductions by performing IS assessments and implementing IS system configuration changes
* Participate in Computer Software Validations
* Solving complex problems, project management, lifecycle management and operational excellence
* Develop, manage and support GxP change control requests per established SOPs and processes
* Support cyber security initiatives tracking and scheduling the deployment of OS Patches Day to day vendor management and contract negotiations with focus on Quality and/or Laboratory information systems suppliers
* Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations
Requirements
Technical Competencies
Experience with LIMS and Empower is desirable. Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals; ICH and GMP guidelines desirable in relation to Lab IT requirements. Experience with regulatory/customer audits is desirable.
Qualifications
University degree in related science/IT/quality discipline or relevant vocational qualifications required.
Skills
LIMS, Empower, Nugenesis, SmartLab, Windows, MS Active Directory
Benefits
* Bonus
* Life Assurance
* Paid Holidays
* Parking
* Pension
* VHI
Others
Shift work and business travel may be required for this position as directed by departmental management.