US ~ Garnet Valley, PA
Pharmaceutical Systems Administrator
Our growing and successful business comprises of over 900 talented individuals globally, in an environment where everybody counts and is instrumental to our success. With state-of-the-art manufacturing and clinical facilities in the UK and USA, we deliver a full range of drug development solutions around the globe saving our clients both time and money.
People join Quotient Sciences because we are a respected member of the drug development world, specialising in delivering innovative solutions that integrate formulation development, real time GMP manufacturing and clinical testing We pride ourselves on the quality of our services and our engaged culture. We are passionate about helping our customers get new medicines to market.
Responsible for administrating the GMP systems software and applications supporting laboratories, manufacturing, facilities and supply chain including any projects for implementation, upgrades or maintenance of these systems software/applications
To ensure the software and applications comply and adhere to regulatory expectations, such as 21 CFR Part 11 and Good Manufacturing Practice (GMP) standards
Main tasks and responsibilities will include:
- Act as Systems Administrator for all software and applications, including but not limited to, Labware LIMS and EMPOWER
- Manage the deployment, set-up, configuration, validation (IQ/OQ/PQ, validation plans, user requirements, software requirements, risk assessments, using GAMP requirements), improvements and upgrade implementation, maintenance, develop custom reports and execution of test scripts for the software and applications
- Configure system workflows and processes to support continuous improvement and the needs of the business. Analyze the effectiveness of business processes mapped in the system and suggest/implement improvements as needed
- Identify integration opportunities among systems and work as global system administrator where needed.
- Develop and maintain Standard Operating Procedures (SOPs), protocols, change controls, action plans, and other technical documents for software and applications
- Partner with the functional area staff and ITS for troubleshooting including leading and coordinating technical issue investigations and manage technology resolution implementations
- Manage of static data within software and applications
- Maintain current user access to software applications and support users by responding to change requests and training needs to new and existing employees
- Collaborate with vendors on upgrades and improvements, including installation and validation of new software revisions to maintain the software and applications in validated status in the latest versions of those software or applications
- Independently plan, manage and execute assignments, contribute to project planning meetings, communicate any changes in plans or timelines
- Ability to communicate clearly and write in a technically proficient manner within a regulatory environment including protocols, reports, and SOPs
- Assure that all work is performed in compliance with all state and federal regulations and guidelines including FDA, EPA, OSHA and DEA. Assures group complies with all company and site policies and procedures
- Remain current in profession and industry trends including pharmaceutical GMPs and 21 CFR Part 11 regulations, software and technology
- Ability to work independently and as part of a team with internal and external vendor teams
- Analyze and determine best solutions based on needs and company goals, provide recommendations based on best industry practices
The job may involve the following:
- Very high concentration of work
- Strict and tight deadlines
- Having to juggle a range of tasks/issues simultaneously
- Working in a hazardous environment with high requirement to follow safety procedures
- Working outside normal working hours
- Needing to respond to client demands
- B.S./B.A. or equivalent with at least five (5) years of experience implementing, managing and/or administration of software and applications, such as LIMS, chromatography data systems, etc.
- Hands on/ bench level experience in analytical techniques is highly desirable
- Experiecne of Computerized System Valdiation process, GAMP guidelines, 21 CFR Part 11, Project Life Cycle ans cGMP regulations governing GxP data
- Proficient in computer applications (Microsoft Office, ERP, data analysis software, etc.)
In return you will receive a competitive salary, a generous benefits package, excellent training and development, as well as an exciting career within a fast paced and dynamic business.