About this role
Senior QA engineer focused on risk management for Third Party Manufacturing (TPM) with responsibilities including investigations, product quality reviews, and regulatory liaison.
Key Responsibilities
- Maintains liaison with AbbVie areas; ensures TPM production adheres to GMP/cGMP; review/approve manufacturing directions; support global projects; annual Product Quality Review; participate in Trend Review Board and Global Change Review Board; change management plans
Technical Overview
QA for TPM with GMP/cGMP compliance; SAP/LRMS experience; strong emphasis on investigations, CAPA, and product quality review.
Ideal Candidate
The ideal candidate is a senior quality engineer with strong GMP/cGMP expertise, experience with TPM and biologic manufacturing, and a track record coordinating investigations and Product Quality Reviews across sites.
Must-Have Skills
Bachelor's degree preferably in Engineering or ScienceSix years of experience within Pharmaceutical operationspreferably Biologic manufacturing processKnowledge of GMP regulations and standards affecting pharmaceutical productsComprehensive knowledge and application of business and quality conceptsStrong analytical skills and attention to detailChange planException ReportsSAP and LRMS experience is highly preferredProven ability to adapt communication style for a variety of modes as well as for multicultural audiencesStrong interpersonal relations / communications skills. Ability to effectively communicate across all levels of the organization
Required Skills
GMPcGMPinvestigationsCAPAchange managementSAPLRMSproduct quality reviewtrend analysisregulatory submissionsTPM
Hard Skills
GMPcGMPInvestigation managementCAPAChange managementSupplier change notificationProduct Quality ReviewTrend analysisGCRBSAPLRMS
Soft Skills
communicationinterpersonal skillsproblem solvingteamworkattention to detail
Keywords for Your Resume
senior quality engineerrisk managementpharmaceuticalgmpcgmpsaplrmsproduct quality reviewchange managementinvestigationsregulatory submissionsthird party manufacturingtrend review boardglobal change review boardpqaquality assurancebiologic manufacturingdata analysis
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