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Assoc Director, QA Validation
| Details |
Country: USA
Location: Andover MA
Total applied: 40
Location: US-MA-Andover Company:Wyeth Job Description:
Job Duties & Responsibilities:
Responsible for the Quality Assurance Validation activities of validation operations within the SPS site. Partners with the Operations group in providing Quality support of their validation projects at the External Supply Sites. Will also partner with Quality Cells and Functions providing Quality support of projects within these groups as it impacts SPS objectives.
Performs operations necessary to support the design, implementation and validation of manufacturing, laboratory and compliance based business systems.
Reviews and approves validation documentation for adherence to Company and regulatory requirements.
Ensures compliance to the validation life cycle by providing leadership and facilitation of change control processes.
Identifies current and anticipated requirements for compliant operations and suggests methods for the identification, implementation and maintenance of the procedures, actions and documentation necessary to assure compliance within the organization according to the appropriate federal and international regulations.
Requirements:
Minimum of a Bachlors Degree in Life Sciences. 14+years experience in regulated environment in Quality Assurance, Manufacturing, Validation and Compliance (MS w/ 10+ yrs). Must be knowledgeable of the processes of Aseptic Filling, Cell Culture/Purification, Lyophilization and Packaging/Shipping. Strong organization and communication skills are necessary. Demonstrated leadership abilities and commitment to team based leadership principles are required.
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.
For more information, visit our website at http://www.wyeth.com
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 prior with Wyeth 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. Requirements: Please see Job Description
Apply By Email:
Ref ID: 46475279
Leading the way to a healthier world.
For your privacy and protection, when applying to a job online: Never give your social security number to a prospective employer, provide credit card or bank account information, or perform any sort of monetary transaction. Learn more >> |
|
Assoc Director, QA Validation
Job Duties & Responsibilities:
Responsible for the Quality Assurance Validation activities of validation operations within the SPS site. Partners with the Operations group in providing Quality support of their validation projects at the External Supply Sites. Will also partner with Quality Cells and Functions providing Quality support of projects within these groups as it impacts SPS objectives.
Performs operations necessary to support the design, implementation and validation of manufacturing, laboratory and compliance based business systems.
Reviews and approves validation documentation for adherence to Company and regulatory requirements.
Ensures compliance to the validation life cycle by providing leadership and facilitation of change control processes.
Identifies current and anticipated requirements for compliant operations and suggests methods for the identification, implementation and maintenance of the procedures, actions and documentation necessary to assure compliance within the organization according to the appropriate federal and international regulations.Requirements:
Minimum of a Bachlors Degree in Life Sciences. 14+years experience in regulated environment in Quality Assurance, Manufacturing, Validation and Compliance (MS w/ 10+ yrs). Must be knowledgeable of the processes of Aseptic Filling, Cell Culture/Purification, Lyophilization and Packaging/Shipping. Strong organization and communication skills are necessary. Demonstrated leadership abilities and commitment to team based leadership principles are required.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.For more information, visit our website at
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