Primary resource for the development, execution, review, and approval of Computerized Systems Validation, 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. Provides guidance for equipment/software related issues and consults with Equipment Owners, IT and QA Management to resolve complex quality issues in a timely manner.

• Works cross functionally with Equipment Owners, IT, and QA Representative for Equipment/Software Validations.
• Write, execute, review, or approve Equipment and Software Validations (IQ, OQ, PQ), in addition to guiding peers in the writing and execution of Equipment and Software Validations; work with IT and applicable system vendors in creating test scripts as required.
• Collaborate with testing and manufacturing personnel, system vendors, IT, and QA to support new systems introduction for GXP use (including support with developing URS and FDS).
•  Write, execute, review, or approve Change Controls; assess impact to qualified state of systems for proposed changes; develop appropriate mitigation plan, as applicable.
• Participates in generating impact assessments, risk assessments, requirements traceability, URS, FDS, procedural mappings and Validation Project Plans.
• 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 Validation Management.
• Participate in quality and process improvement initiatives, and project teams.
• Participate as needed to support Client and Regulatory audits.
• Works on routine assignments per written procedures, where ability to recogniz 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
• Contributes to the overall operations and to the achievement of departmental goals
• Perform job specific tasks in compliance with applicable Regulations, International Standards, and WuXi AppTec Policies and Standard Operating Procedures.
• Thorough understanding of Good Laboratory Practices and Good ManufacturingPractices
• Other duties as assigned
• May be required to assist in other departments

Experience / Education

• 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

Physical Requirements:

• Must be able to work in an office environment with minimal noise conditions.
• Must be able to work in Lab setting with Biohazards /various Chemicals
• Must be able to wear appropriate PPE
• Ability to stand /Sit/walk for long periods of time