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, lead internal and external laboratory audits, provide technical review of data and documentation, and serve as a project leader to manage special initiatives and improvement teams.
Other Key Responsibilities:
Participate in and lead improvement projects with an emphasis improving systems within a continuous improvement framework.
Represent department for internal and external 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
Lead process harmonization initiatives to support successful analytical technology transfers with other Perrigo sites, Quality & in-license partners
Review metrology and stability data, perform stability study administration, and assist in implementation of new laboratory equipment
Develop and maintain departmental metrics and capacity models
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
Develop and implement innovative functionality in applications as required by evolving business need
Collaborate with IT and QA Validation Departments to facilitate computer system validation activities; developing and/or executing test scripts as required
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 3 years of relevant experience in a cGMP or cGLP laboratory
Excellent computer, 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.
Familiarity with computer systems validation and customizable software applications (such as SharePoint, electronic notebooks, chromatographic data systems, 3and laboratory information systems) is a plus
Perrigo Company Corporate