Senior Quality Control Specialist - E-Systems & Compliance I am seeking an exceptional candidate for my client, a prominent biopharma company based in Limerick, Ireland.
The Senior Specialist/ Expert Specialist-Esystems is a member of the Quality Control Laboratory and is responsible for operational and technical support of the laboratory electronic systems used to perform analytical testing, recording and reporting of analytical test results. The electronic systems include systems such as the laboratory information management system LabVantage, Water's Empower chromatography system and MODA.
Specifically, the Specialist-Esystems will be expected to be a collaborative, inclusive, energetic technical resource in support of the QCL function.
Responsibilities:
System administrator for Esystems utilized in the QC laboratory.
Provides first level end-user support for QCL electronic systems including troubleshooting problems at the application layer within their permission level and escalating as appropriate.
Works with IT, CSV and the Quality department ensuring the QCL Electronic systems are implemented following a development life cycle approach.
Knowledgeable of general scientific methods and operation of associated Esystems.
Configures master data, worksheets, methods and reports (tabular, trend and labels) within the QCL electronic systems in a compliant manner.
Supports the Authoring of key GMP documents such as GMP standard operating procedures, training materials, test methods creation documents, local qualification documents, etc.
Coordinates with other team members implementing the electronic systems in an efficient manner.
Processes and supports QCL Informatics Change Control requests and CAPAs.
Supports Audit requests relating to QC Esystems in a timely manner.
Provides application assistance prior to, during and post Regulatory/Partner inspections.
Supports the collation of QCL and other departmental metrics from the QCL electronic systems.
Basic Requirements:
Hons Degree Qualified – B.Sc. in Chemistry, Microbiology, Information Technology or related discipline, with a minimum of 2 years relevant GMP experience.
Additional Skills/Preferences:
·Safety first approach to all activities.
·Strong Quality and Data Integrity mindset in a QC environment.
·Proficient in English.
·Experience with Quality Control applications e.g. Lab Vantage, MODA,
Empower, NuGenesis, and benchtop applications such as DataPro2, SoftMax Pro.
Key Attributes:
Business Knowledge: High performance in delivery of their work. Looks at better, simpler ways, takes initiative and will run proactively with actions. Demonstrated self-management, prioritisation, and organisational skills.
Learning agility and Curiosity: High learning agility and flexibility and ability to deal with ambiguity and uncertainty. Demonstrated ability to identify and prioritize problems, develop, and implement solutions.
Positive Influence: Demonstrated ability to address issues as they arise and take act. Trusted in the team to follow through on actions.Is interested in own performance and seeks feedback to improve.
Relationship Builder: Demonstrated ability to establish and maintain key relationships across all levels in the organisation.
Communication: Demonstrated strong communication skills, written and oral in 1:1 and group situations.
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