Michigan, Grand Rapids-Muskegon-
Prepare and coordinate validation events in conformance with cGMP and FDA requirements. Prepare and/or review validation plans, protocols and reports along with other deliverables associated with validation activities.
: Reviews technical documents to ensure that validation acceptance criteria are consistent with specifications.
: Prepares and/or reviews deliverables associated with validation activities.
: Ensures that validation events occur in conformance with approved procedures.
: Assesses deviations and recommend corrective actions as necessary
: High level of analytical skills with proven problem-solving ability, and excellent interpersonal skills.
: Demonstrated ability to organize multiple tasks and to change priorities to meet project deadlines.
: Working knowledge of electronic record and signature regulations applied to computer systems.
: Ability to write technical documents relating to applications and computer systems of complexity.
: Demonstrated thorough understanding of validation processes and interpretation and application of FDA and cGMP requirements.
: Bachelor' s degree in Computer Science, Engineering, Programming, or a related field.
: Five years plus pharmaceutical industry experience preferred.