Perrigo Company is dedicated to making lives better by bringing high quality and affordable self-care products that consumers trust everywhere they are sold. Help us do it.
The professional in this role will provide leadership and support to maintain and improve Analytical R&D laboratory systems with an emphasis on supporting laboratory-based software applications. In addition, this professional will participate in internal and external audits, provide technical review of data and documentation, and serve as a project leader to manage special initiatives and improvement teams.
- Manage laboratory software lifecycle (select, acquire, develop, validate, deploy, monitor/audit and retire)
- Collaborate with IT and QA Validation Departments to facilitate computer system validation activities; developing and/or executing user acceptance tests
- Provide timely and accurate support for departmental SharePoint sites, Electronic Laboratory Notebook (ELN), Scientific Data Management Systems (SDMS) and other laboratory information applications for internal and external users
- Explore platforms for data visualization (JMP and Power BI)
- Develop and implement innovative functionality in applications as required by evolving business needs
- Participate in and lead improvement projects with an emphasis on improving systems within a continuous improvement framework
- Represent department for internal and external audits and perform monthly department audits
- Partner with other groups (on-site and other Perrigo global sites) on special initiatives and teams
- Create and update best business/compliance practices for efficiency and robustness
- Contribute subject matter expertise in data governance, data integrity and data analytics
- Update and maintain documentation associated with ELN and ALIMS (such as Work Instructions, Functional Requirements, Change Control)
- Create, review, and train department on SOP and departmental Business Process Procedure revisions
- Attend and actively participate in project and departmental meetings
- Review regulatory requirements (USP/NF, FDA, ICH, CFR, other compendia) to provide and implement proposed recommendations or requirements
- Bachelor’s degree in Chemistry or related sciences with a minimum of 2 years of relevant experience in a cGMP or cGLP laboratory
- Familiarity with computer systems validation and customizable software applications (such as SharePoint, electronic notebooks, chromatographic data systems, and laboratory information systems) is a plus
- Excellent written and oral communication skills
- Strong presentation skills
- Quality and detail-oriented documentation skills
- Ability to effectively interact with all levels of the organization to achieve goals and influence decisions
- Ability to solve complex problems independently and with teams
- Thorough working knowledge of cGMP, cGLP, FDA regulations, and ICH guidance documents
- Proficiency in managing multiple projects, prioritization, and organization.
Equal Employment Opportunity/M/F/disability/protected veteran status.