The Laboratory Systems Manager is responsible for all Quality Laboratory System activities to ensure all relevant activities comply with GMP and Regulatory requirements.
You will lead the key Quality Laboratory support functions within a team-based organization and achieve high standards of engagement and compliance.
The Cork site is welcoming exciting growth and new expansions to support the strong product pipeline coming through.
Duties and Responsibilities:
Responsible for ensuring Laboratory equipment calibrations, equipment qualifications, procedures are approved
Responsible for the Quality Laboratory reference standard and calibration programme
Responsible for the Quality Laboratory Sample Management programme
Identify capital budget requirements and obtain quotes as appropriate.
Procure\upgrade of laboratory equipment as required
Drive the implementation of new instrumentation in the Quality Laboratories
Prepare and support laboratory groups for internal audits, external audits and Regulatory Inspections
Responsible for ensuring Data Integrity Controls are in place to support Laboratory Operations
Responsible for System Administration for laboratory instruments (including hardware and software)
Support completion of actions for Site Data Integrity plan
Lead the improvement of the site’s Quality Laboratory systems, ways of working, and culture, including changes that improve the capability, capacity, culture, and standards at the site.
Promote and support value-added continuous improvement, using a risk based approach.
Serve as a Role Model Leader demonstrating strong communication and interactions with colleagues at all levels, promoting positive employee relations.
Emphasizing the critical need for on-time delivery through the lens of full compliance
Manage resources for Quality Laboratory System group
BSc Hons Degree Science, and/or higher degree
Experienced in a pharmaceutical laboratory environment
Proven experience and ability to lead and motivate within a team. Highly talented at team building, coaching and mentoring with a passion for inspiring others.
Understanding and ability to adhere to established quality standards and regulatory compliance requirements preferred.
Collaboration skills – Able to effectively collaborate with peers in other functions and with colleagues in other businesses or divisions
Ability to manage multiple priorities and projects in a cross-functional environment.
Ability to apply data analytics and risk-based decision making.
For a confidential discussion and more information on the role, please contact Rory Walsh.