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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

• Cross functional Metrology and QA Representative for Equipment/Software Validations

• Write, execute, review, or approve Equipment and Software Validations (IQ, OQ, PQ).

• Write, execute, review, or approve Change Controls.

• Write, review, or approve Periodic Reviews.

• Stay current with changes to GXP, including FDA and EU and other regulatory bodies as well as guidance documents (i.e.: ICH, ISPE, GAMP, ISO, etc.).

• Interact frequently with laboratory/manufacturing/facility staff to provide expertise on equipment/software validations. Address conditions/practices with appropriate personnel, reports findings to QA Management.

• Issues, reviews, or approves document change requests.

• Perform QA inspections including, but not limited to, Internal Audits and Supplier Audits.

• Participate in quality and process improvement initiatives, and project teams.

• Coordinates area training.

• Participate as needed to support Client and Regulatory audits.

• Works on routine assignments per written procedures, where ability to recognize deviation from accepted practice is required.

• Normally receives minimal instructions on routine work and detailed instructions on new assignments.

• Ability to work in a team environment and independently as required

Qualifications

• 8+ years of relevant experience or equivalent

• Bachelors’ degree in a Science related field or equivalent experience

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.

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Job Locations US-PA-Philadelphia

Job ID 2024-12714