At Wyeth, we have a vision of leading the way to a healthier world. We've committed ourselves to achieving this vision by making quality, integrity and excellence the hallmarks of our business. A Fortune 500 company and global leader in pharmaceuticals, consumer healthcare, and animal healthcare products, we know that our employees are who keep us on the cutting edge of innovative discoveries and superior customer service. To sustain and enhance our leadership position in the pharmaceutical industry, we continue to recruit, develop and motivate individuals whose skills, values, and work ethic will grow and improve our business.
Job Summary
Oversight of the development and implementation of GMP analytical laboratory data management systems within Analytical & Quality Sciences, such as laboratory information management systems (LIMS), chromatography data acquisition systems (CDAS), and data archival systems. Acts as Project Manager and liaison with Wyeth IT/IS groups for scoping and implementation of new analytical laboratory data-management projects. Assists in recognizing improvement opportunities for data and information flow in the department. Writes and ensures GMP documentation (qualification, validation, and SOPs) in support of these systems are in place. Provide expertise for AQS in electronic data systems including potential areas such as electronic laboratory notebooks. AQS department representative for computer system issues in external/internal meetings. Provide training to staff. May involve staff management.
Job Responsibilities
Oversee the development and implementation of GMP analytical data management systems within Analytical & Quality Sciences, such as laboratory information management systems (LIMS), chromatography data acquisition systems (CDAS), and data archival systems. May involve system administrator responsibilities for system control and maintenance. Assists in audits on these systems.
Manage all IT projects within AQS to insure that new systems and technologies are implemented and validated to meet laboratory needs, company objectives and workload timelines in a compliant manner. Provide technical support and leadership for all AQS projects with IT components.
Propose improvement projects for current systems and technologies, including data and information workflow in the laboratory. Assess current systems and technologies for compliance gaps and ensure that plans are in place to accomplish compliance goals. Ensure that validation documentation and operating procedures exist for all appropriate systems.
Writes and ensures GMP qualification, validation, associated computer documentation (periodic reviews, user/functional requirements, etc.) and SOPs in support of these systems are in place.
Other job duties as assigned.
Basic Qualifications
BS/BA, MS/MA; Chemistry, Computer science, or equivalent
A minimum of 10 years of relevant experience is required.
Knowledge of hardware, network (infrastructure), and applications relating to chromatographic data collection and processing. Previous experience in GMP-GLP compliance-related activities (documentation, assessment, etc.) for computer data management systems is required. Thorough knowledge of analytical laboratory functions and data types generated in support of new drug development. Previous laboratory experience is preferred. A minimum of 10 years direct experience in laboratory and data management syustems is required.
Relocation is not available for this position.
Wyeth offers competitive compensation and benefits programs, including child-care subsidies, flex-time, business casual attire, educational assistance and professional development programs.
For more information and to apply online, please visit us at: www.wyeth.com/careers
Wyeth is an Equal Opportunity Employer, M/F/D/V.
Search Firm Representatives:
Please Read Carefully.
Wyeth is not seeking assistance or accepting unsolicited resumes from search firms for this employment opportunity. Regardless of past practice, all resumes submitted by search firms to any employee at Wyeth via-email, the Internet or directly to hiring managers at Wyeth in any form without a valid written search agreement in place for that position will be deemed the sole property of Wyeth, and no fee will be paid in the event the candidate is hired by Wyeth as a result of the referral or through other means. Note: Any search agreement entered into with Wyeth prior to January 2004 is hereinafter void.
Search firms are essential to the recruitment and staffing efforts at Wyeth and we value the partnerships we have built with our preferred vendors. For this reason, Wyeth has established and regularly maintains a preferred vendor list. Please note that even preferred vendors need to have a written search agreement signed by the Vice President, Strategic Staffing at Wyeth in place for the specific position in order for a fee to be paid for any candidate referrals.
Experience: See above.
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Wednesday, September 17, 2008