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QA Validation Specialist IV
| Details |
Country: USA
Location: Andover MA
Total applied: 40
Location: US-MA-Andover Company:Wyeth Job Description:
Independently leads the QA input to validation projects in support of commercial manufacturing. Provides input into strategy and direction to project teams on compliance/technical issues related to validation efforts to achieve compliance with company policies and government regulations. Reviews and approves validation documentation including specifications, protocols and reports with a focus on cGMP impact and validation lifecycle requirements.
Independently reviews validation documentation for compliance with company policies and government regulations. Document approval including specifications, protocols and reports with a focus on cGMP impact and validation lifecycle requirements.
Participates on validation project teams and provides guidance and direction from a regulatory compliance perspective. Actively and independently steer project teams to meet company policies and government regulations.
Acts as mentor for junior members of staff and to provide coaching and guidance on company policies and regulatory requirements.
Authors/reviews/approves departmental SOPs as and when appropriate, to actively participate in departmental staff meetings.
Requirements:
B.S. in relevant, science based discipline
M.S. in relevant, science based discipline
Training in local SOPs and policies
Expected to be proficient in validation and GMP regulations
B.S with 10yearsM.S. with 8 years
Proven expertise in compliance and validation
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: 46768702
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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 >> |
|
QA Validation Specialist IV
Independently leads the QA input to validation projects in support of commercial manufacturing. Provides input into strategy and direction to project teams on compliance/technical issues related to validation efforts to achieve compliance with company policies and government regulations. Reviews and approves validation documentation including specifications, protocols and reports with a focus on cGMP impact and validation lifecycle requirements.Independently reviews validation documentation for compliance with company policies and government regulations. Document approval including specifications, protocols and reports with a focus on cGMP impact and validation lifecycle requirements.Participates on validation project teams and provides guidance and direction from a regulatory compliance perspective. Actively and independently steer project teams to meet company policies and government regulations.Acts as mentor for junior members of staff and to provide coaching and guidance on company policies and regulatory requirements.
Authors/reviews/approves departmental SOPs as and when appropriate, to actively participate in departmental staff meetings.Requirements:
B.S. in relevant, science based discipline
M.S. in relevant, science based discipline
Training in local SOPs and policies
Expected to be proficient in validation and GMP regulations
B.S with 10yearsM.S. with 8 years
Proven expertise in compliance and validationWyeth 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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