QA Validation Specialist

Job Duties and Responsibilities:
This is compliance-based position within the Quality Units' change control team. The duties of this position include, but are not limited to, the oversight of the change control process with a focus on manufacturing systems, laboratory systems and business systems that support commercial operations as well as systems that are shared between the commercial and development organizations. In this role, you will use your industry experience to collaborate with internal partners and to facilitate the change control process. Your contributions will have a direct and measurable impact on the success of the team. The candidate must have a good working knowledge of cGMP. A working knowledge of 21 CFR 11 would be an advantage but is not essential. Knowledge of TrackWise is an advantage, as this role will rely heavily on this computer-based application for the tracking of change control items, but training will be given. You must be a self-starter, be extremely attentive to detail, organized, creative and willing to contribute to the success of the team. The successful candidate must be willing and able to lead/facilitate change control meetings and be able to work with staff at all levels to facilitate the implementation of changes in the commercial manufacturing environment.

Requirements:
4+ Years of experience in a Regulated Pharmaceutical Industry (e.g. FDA, EMEA etc.)A B.S. in Life Sciences/Engineering/Computer science or other relevant discipline Knowledge of validation and change control Core understanding of biopharmaceutical processes Ability to collaborate across cross-functional areas and work in a matrixed team environment. The ability to coordinate multiple activities and effectively set priorities.



Wyeth offers competitive compensation and benefits programs including stock
options, child-care subsidies, flex-time, business casual attire,
educational assistance and professional development programs. Please
forward your resume with salary requirements and job reference code to the
address below.

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