Job summary:The IT Software Validation Specialist position is responsible for developing, reviewing, and
executing validation documentation including Validation Plans/Reports, , Installation
Qualifications (IQ), Operational Qualifications (OQ), Performance Qualifications (PQ) and test results to maintain computerized systems and applications in a validated state.
Essential job functions:- Design and implement validation deliverables / test plans and test cases, based on system understanding and analysis of user, functional and system specifications.
- Ensure new GxP software / computer systems and changes to existing systems are maintained in a state of control.
- Ensure accuracy and completeness of Software Development Lifecycle and/or IT Validation records (e.g., Validation Plan, IQ, OQ, PQ, Minor Change Record)
- Collaborate with business users and Business Analysts to understand user requirements and functional design specifications.
- Analyze test results and attach evidence to ensure acceptance criteria are adequately met; provide software QA approval to proceed with subsequent activities.
- Ensure test case failures or bugs are adequately investigated and resolved.
- Participate in release planning sessions to meet release schedule
- Ensure timely documentation of Protocol or minor change records and lifecycle documentation.
- Participate in process improvement efforts
- Perform other duties as assigned.
Regulatory & Compliance- Know and follow applicable regulatory requirements (GMP, GLP, ISO, etc.).
- Know and follow company policies and procedures.
Professional Development- Complete required training on time.
Job requirements:- Well versed with software lifecycle processes and methodologies, with an emphasis on quality assurance and testing best practices
- Proficient understanding of Pharmaceutical and Medical Device regulations including but not limited to 21CFR Part 11, 21 CFR Part 210/211, 21CFR Part 820, 21CFR Part 1271 and ISO 13485
- Demonstrated technical writing skills
- Working knowledge of MS Office applications
- Ability to multi-task and deal with changing deadlines
- Ability to troubleshoot complicated issues across multiple systems, regardless of architecture and driving the effort to a successful conclusion
- Ability to work with minimal supervision, managing own time effectively
- Demonstrated logic, problem solving, and decision making skills
- Regular and reliable attendance
Physical requirements:- Must be able to stand/walk 10% of the day and 90% spent sitting at a desk or on the computer. Must be able to occasionally lift a minimum of 10lbs.
Education and experience requirements:- BS degree in Engineering, Computer Science or Physical/Life Science; Associate degree or equivalent experience required.
- At least 2 years in a BA, QA, Laboratory or IT role
