Pfizer
Quality Assurance Manager - Validation
Pfizer, Groton, Connecticut, us, 06349
Quality Assurance Manager - Validation (Contract)
Groton, CT, United States (On-site)Contract (12 months)Published a week agoSummary:As a Quality Assurance Manager – Validation, the successful candidate will play an integral part in the QA oversight of Validation and Qualification activities conducted within the Pfizer Groton, CT site.Responsibilities:Provide validation and qualification guidance to customers for equipment and computerized systems related to solid dosage manufacturing, API manufacturing, laboratory instrumentation and related utilities (e.g., water, nitrogen, etc.)Review and approval of validation system life cycle documents including Validation Plans, IQ/OQ/PQ, vendor assessments, design documents, reports, procedures and periodic reviews. Quality lead on large projects and contributes to validation strategy.Participate and/or lead quality investigations including root cause analysis, Pfizer Human Performance assessments, and approval of investigation reports.Review and approve change controls, quality investigations, and corrective/preventive actions.Participate in the development of procedures which increase efficiency while maintaining high quality standards.Provide support to internal audits (e.g. MSQA) & regulatory inspections (e.g. FDA, MHRA) as needed.Participate on special projects, teams and global initiatives.Qualifications:Bachelor’s Degree (B.S.) required.A minimum of 3-5+ years of technical/scientific/pharmaceutical experience/Engineering or equivalent.Must have 3-5+ years of relevant work experience in a cGMP pharmaceutical manufacturing or R&D environment.Extensive knowledge of cGMP’s related to equipment and computer system validation/qualification preferred.Expertise in quality investigation techniques preferred.Experience with Quality Risk Management (QRM) preferred.Previous quality assurance experience preferred.Rate/Hours:$34 - $39 per hour.This is a fully onsite role in Groton, CT.Monday - Friday; 1st Shift.
#J-18808-Ljbffr
Groton, CT, United States (On-site)Contract (12 months)Published a week agoSummary:As a Quality Assurance Manager – Validation, the successful candidate will play an integral part in the QA oversight of Validation and Qualification activities conducted within the Pfizer Groton, CT site.Responsibilities:Provide validation and qualification guidance to customers for equipment and computerized systems related to solid dosage manufacturing, API manufacturing, laboratory instrumentation and related utilities (e.g., water, nitrogen, etc.)Review and approval of validation system life cycle documents including Validation Plans, IQ/OQ/PQ, vendor assessments, design documents, reports, procedures and periodic reviews. Quality lead on large projects and contributes to validation strategy.Participate and/or lead quality investigations including root cause analysis, Pfizer Human Performance assessments, and approval of investigation reports.Review and approve change controls, quality investigations, and corrective/preventive actions.Participate in the development of procedures which increase efficiency while maintaining high quality standards.Provide support to internal audits (e.g. MSQA) & regulatory inspections (e.g. FDA, MHRA) as needed.Participate on special projects, teams and global initiatives.Qualifications:Bachelor’s Degree (B.S.) required.A minimum of 3-5+ years of technical/scientific/pharmaceutical experience/Engineering or equivalent.Must have 3-5+ years of relevant work experience in a cGMP pharmaceutical manufacturing or R&D environment.Extensive knowledge of cGMP’s related to equipment and computer system validation/qualification preferred.Expertise in quality investigation techniques preferred.Experience with Quality Risk Management (QRM) preferred.Previous quality assurance experience preferred.Rate/Hours:$34 - $39 per hour.This is a fully onsite role in Groton, CT.Monday - Friday; 1st Shift.
#J-18808-Ljbffr