Computerized Systems Compliance & Validation Specialist
Computer Systems Compliance/Validation Specialist
Toxikon Corporation, originally founded in 1977, is a Contract Research and testing company with laboratories in Bedford, MA and Belgium. Our mission continues to focus on providing quality services, competitively priced, with on-time delivery for the Pharmaceutical, Medical Device and Biotech industries.
Job Duties and Responsibilities
- Oversight and documentation compliance of electronic systems including archiving processes, including training for appropriate user groups.
- Complete SOP for clinical instrumentation qualification procedures, validation and work with Metrology and Validations Services (MVS) department on implementation.
- Audit all required SOPs for compliance to FDA and other computerized system guidance documents.
- Interface with quality assurance and laboratory operations as part of the Information Technology Group (IT) in structuring and implementing automated reporting templates to ISO and other standards.
- Complete review of standalone computer systems, process controls, passwords (per 21 CFR Part 11 requirements) and keep information current for all departments.
- and assist with the implementation and validation of automation with vendors
- Create post validation help desk documentation-CAPA system-work with IT /QA to close out all open tickets
- Create training program for 21 CFR Part 11 methodology and perform the training
- Assist QA and IT in all vendor and FDA/other audits related to computerized systems
- Participate in software system evaluations for regulatory compliance.
- Perform gap analysis on applications to address regulatory requirements such as Part 11.
- identify and document risk assessments.
- Take leadership role in all computerized system validations.
- Maintain compliance with master validation plan and keep MVP and other documentation current.
- Perform code review for any custom code applications.
- Assess and manage regulated from non-regulated business processes together with QA and IT
Qualifications and Experience
- Associate’s or Bachelor’s degree in a technical or science field.
- 2-4 years’ experience working in regulated software systems.
- Attention to detail critical
- Strong interpersonal, writing, and communication skills.
- Proficiency in commonly used business applications.
- Working knowledge of SQL databases is a plus.
- Familiarity with statistical software is a plus.
- Knowledge of FDA 21 CFR Part 11 is a plus.
This is not a software QA position.
For additional information please visit our website at www.Toxikon.com.
Submit resumes to:
15 Wiggins Avenue
Bedford, MA 01730
Toxikon employs 160 people and offers a generous benefit program including health, dental, fsa, std, ltd, life insurance and matching 401K plan. Toxikon is an EOE.