- Ensure Frontage lab global computer system validation program meets both business and regulatory requirements. Assist with client and FDA audits as necessary.
- Provide validation support for Bioanalytical, DMPK, Biologics, Clinical and IT as needed.
- Leverage validation efforts across sites and enterprise computer system solutions as appropriate.
- Provide support, training and guidance for validation projects.
- Maintain a computer inventory of computer system/software.
- Maintain validated state of software through periodic reviews, change controls and review of and implementation of upgrades as needed.
- Provide application support for lab software systems in general. Provide focused support for key systems: i.e., Watson LIMS/Sciex Analyst/QuickBase/IDBS E-WorkBook, eBinder etc.
- Resolve user problems and provide training as necessary.
- Evaluate and implement new software-based technologies as needed.
- Support user account and application access control.
- Manage and interact with system vendor to escalate and resolve issues.
- Provide support, instrument qualification and software validation, enhancement, and administration of laboratory instruments and related software.
- Support lab software application configurations related to lab instrumentations.
- Complete documentation for the support of software changes and upgrades.
- Drive technology improvements and efficiency opportunities to improve business and compliance.
- Contribute to change controls and procedures specific to laboratory software.
- Coordinate/interface/host vendors on site, when applicable.
- Point of contact for communication between Corporate IT and laboratory groups.
- Provide training in software access and functionality.
- Ensure the software applications are validated to 21 CFR Part 1 compliance and always maintained in validated state.
- Responsible to lead and manage the Computer System Validation (CSV) Team
- Other duties as assigned.
- Bachelor's degree in relevant scientific, engineering, or computer-based area with 10 years' experience in the pharmaceutical industry or equivalent combination of education and IT and/or lab experience.
- Knowledge of GxP regulatory requirements, computerized analytical systems (i.e., 21 CFR part 11) and data integrity.
- Expert in lab systems such as Watson LIMS, IDBS eNotebook,, NUGENUSIS, Waters' Empower Administration and other software programs, including Microsoft Office Applications.
- Must have GxP experience.
- Excellent organization, planning, and communication skills.
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Team Leader Computer System Validation - Exton, United States - Frontage Laboratories
Description
Job Description
Job DescriptionTeam Leader, Computer System Validation and Application Support
Title: Team Leader, Computer System Validation and Lab Application Support
Location: Exton, PA
Reports to: VP, QA and IT compliance
Full-time (40 hrs./week)
Frontage Laboratories Inc. is an award winning, publicly listed (HKSE), full-service CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada, and China, and growing over 30% YOY. Our core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials.
Position/Job Summary:
As a leader and subject matter expert (SME), the Team Leader, Computer System validation and application define and maintain Frontage lab computer system validation program and responsible for testing, implementation, validation and date to date support of software applications. Lead the corporate validation team to achieve operational excellency.
The primary responsibilities of this position will be to provide leadership in lab software/application implementation and validation, administration, data management, user support, troubleshooting cross Frontage lab to meet GxP requirements on computer systems in lab.
Roles & Responsibilities:
Education, Experience & Skills Required:
Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.
