The successful candidate will assure software validation compliance with applicable regulatory requirements including documentation generation, review and approval, training and vendor auditing.
Primary Duties and Responsibilities
- Manage the software validation program, including generating, reviewing and approving validation documents and performing risk and US 21 CFR Part 11 and EU Annex 11 assessments.
- Manage the software change control system; assess validation requirements of changes/updates to validated software systems including EDMS and laboratory systems.
- Represent and interface with Information Technology and other applicable system owner groups to provide validation and 21 CFR Part 11/Annex 11 guidance’s in an effective manner.
- Trouble-shoot and take the initiative on any QA-related issues for software validation compliance.
- Perform internal audits of validated systems to ensure compliance with procedures and protocols.
- Conduct vendor qualification audits for software vendors.
- Perform CRF and edit check review for data management prior to user acceptance testing.
- Perform training on software validation topics including general software validation, 21 CFR Part 11 regulations and Annex 11 guidelines.
- Develop, revise and review Standard Operating Procedures.
- Provide assistance as necessary in GMP batch record review and/or vendor qualification audits.
- Carry out job responsibilities and assignments safely and maintain a clean and safe work area.
- Bachelor’s (BS) in the Life Sciences or related discipline.
- At least four to six years’ experience demonstrated experience in the QA responsibilities listed above.
- Strong knowledge of 21 CFR Part 11 regulations and EU Annex 11 and good documentation practices.
- Strong writing skills in protocols, SOPs and QA reports.
- Must have ability to listen, communicate effectively (both orally and in writing) and to interact with all levels within the organization. Excellent reasoning, interpersonal and organizational skills, and superior attention to detail.
- Extensive skills, knowledge and abilities with computers and software programs including Word, Excel, and document management programs.
- Experience with regulatory publishing software, clinical operations systems and laboratory analysis systems is a plus.