QC Laboratory Compliance Supervisor – Data Integrity

The primary purpose of this position is to provide leadership and direction to the QC Laboratory Data Integrity Team. The role is accountable to manage data integrity, investigation, personnel training, laboratory documentation, laboratory equipment qualification, calibration and computerized system validation and gap analysis against Pfizer Quality Standard/cGMP and all GMP-related records in QC LaboratoryHow You Will Achieve ItDrive team engagement and effective communication within QC Laboratory Data Integrity TeamActively coordinate with the teams to ensure the project (i.e. laboratory equipment qualification, etc.) in QC Laboratory are delivered in the most effective way and meet target datesMaintain and ensure compliance in Quality and Safety such as submitting CASR, QAR/ER, safety incident and CAPA as per committed in QC LaboratoryReview and approve protocol and report of qualification of laboratory instrumentGuide and accompany analyst during qualification of laboratory instrumentReview computerized system validation result in the QC Laboratory Perform periodic review related to audit trail, user privilege, back-up, restore and data integrity gap assessment for instrument and QC documents Hold and maintain administrator account in equipment and instrument in QC LaboratoryMaintain QC Laboratory documentation and doing Laboratory investigation, Manufacturing investigation and closure of all commitments.Manage calibration activities and review calibration/verification reportManage curricula and training assignment, and ensure training completion in QC LaboratoryRevise SOP, STP and other GMP document in QC Laboratory, as requiredPerform training to QC Laboratory Personnel, as requiredQualificationsMust-HaveGraduate from Faculty of Pharmacy or Chemical Science (S1, Undergraduate Degree)3+ years’ experienceLaboratory supervisory experienceKnowledge of Good Manufacturing Practices {also cGMP} compliance requirements for Quality Control LaboratoriesExperience with leading colleagues and/or projectsStrong people management experienceDemonstrated skills in collaboration, attention to detail, and communication skillsAbility to handle complex and detailed situations with a focus on qualityNice-to-HaveMaster's degreeSix sigma certifiedRelevant pharmaceutical experience.Experience with microbiological risk assessmentsKnowledge of Laboratory Information Management System Empower and Microsoft OfficeWorking knowledge and understanding of requirements as it relates to method qualification and testing of components and finished products Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.Quality Assurance and Control#LI-PFE