Empower 3 Validation Specialist
QAVAENG CONSULTING - Carolina, PR

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Apply on www.qavaeng.com careers section. Candidate will be responsible for Empower 3 validation project. Interaction with internal customers will be inherent to this position as well as the ability to problem solve and prioritize activities to meet project deadlines. Drive the computer validation/Qualification activities including developing/executing software SDLC (Software Development Life Cycle) documents (URS, Functional Requirements, Risk Assessment, Design Specification, IQ, OQ, PQ) to completion. Provide technical expertise, interpretation and direction to management and user departments to assure compliance with regulatory requirements, company policies and standards. Must be available irregular shifts.

Education/Experience

Bachelors degree in Computer Science, Chemistry, Life Sciences or Engineering or related field with EMPOWER VALIDATION EXPERIENCE along with 4 years hands on experience in Computer system validation or equivalent combination of education and experience. Specific knowledge of computer validation methodologies, software development life cycles, extensive knowledge of cGMPs, 21 CFR Part 11, regulatory requirements and ICH guidelines. Knowledge of computer network and system security principles. Working validation knowledge on lab Empower 3, EDMS, LIMS, CDAS, IT infrastructure. Must be proficient in MS-Office. Ability to work independently and drive projects. Excellent written and oral communication skill, good decision making skills and time management skills.