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Must Have: 

Develops validation/qualification deliverables such as Validation Plans, RequirementsSpecifications, Traceability Matrices, Summary Reports, Change Controls.

Knowledge, Skills, and Abilities:

Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, computer systems validation requirements and good documentation practices.Experience in the qualification of cell therapy equipment a plusAdvanced knowledge of pharmaceutical, manufacturing and laboratory systems.Understanding of investigations, deviations and CAPA management in a regulated pharmaceutical industry.Strong written and verbal communication skills.Excellent interpersonal skills with experience dealing with a diverse workforce.Strong multi?tasking ability in conjunction with proven organizational skills. Ability to organize assigned tasks in a high paced environment and concurrently monitor tasks / assignments with others that may impact timely completion. Ability to effectively manage multiple tasks and activities simultaneously.Highly proficient computer skills in Microsoft Office Suite