Wuxi Apptec Philadelphia , PA 19107
Posted 2 months ago
Overview
Primary resource for the development, execution, review, and approval of equipment/software validations (including Computerized Laboratory Systems), System Life Cycle Documentation (Validation Plans, Design Specifications, Requirements Specifications, etc.), Change Controls, Decommissioning Reports, etc., in accordance with 21 CFR Part 11 and GAMP5. Monitors equipment/software processes for adherence to established procedures/regulatory compliance. Provides guidance for equipment/software related issues and consults with QA Management to resolve complex quality issues in a timely manner.
Responsibilities
Qualifications
Knowledge / Skills / Abilities:• Knowledge of 21 CFR Part 11 and ISPE GAMP5 is required.• Knowledge of cGMP requirements, PTC guidelines and ISO17205 is highly desirable.• Ability to accomplish the described duties through the use of appropriate computer equipment and software (Microsoft Word, Excel, Outlook, and Access).• Ability to accurately and reproducibly perform arithmetic, algebraic and geometric calculations. • Ability to record data accurately and legibly.• Ability to use judgment as dictated by the complexity of the situation.• Ability to understand and follow verbal or demonstrated instructions.• Ability to work effectively as part of a team and to exhibit effective interpersonal skills.• Ability to receive, comprehend and to effectively communicate detailed information through verbal and written communication• Proficient in Oral & Written communication skills• Need to be able to read, write and understand English
Our Values:
Integrity & Dedication, Working Together & Sharing Success; Do the Right Thing & Do it Right.
Our greatest asset is our people, WuXi is dedicated to providing opportunities for internal growth with direct access to a dedicated and accessible Human Resources team.
WuXi AppTec provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law.
Wuxi Apptec