Job Title

JOB PURPOSE: Assist Manager, Quality Assurance in the design, implementation and continuous improvement of the companys quality systems to ensure compliance with current Good Manufacturing Practices (CGMP), regulatory agencies, client and corporate expectations.JOB RESPONSIBILITIES:Assist in developing and managing companys quality systems, CGMP compliance and continuous quality improvement projectsOversee and communicate daily priorities and scheduling of QA activities in coordination with other departments (operations, laboratories, supply chain, etc.) Review and approve quality related documents, such as equipment (IQ/OQ), process, computerized systems, analytical methods validations, stability protocols and reports, master batch records and executed batch recordsReview and approve intermediates, in-process controls and cleaning specificationsPrepare, facilitate and respond to audits (regulatory agencies, client and/or internal)Ensure the execution and maintenance of companys quality programs, such as:Vendor Qualification Program, including the reduced testing program and vendor on-site auditsInternal AuditChange Control ProgramCorrective Actions/Preventive Action (CAPA) systemTrending and tracking of quality systems, such as deviations, investigations, CAPAs, Environmental Monitoring, Municipal water quality resultsEnsures that external customer requirements are established and are addressed within the Quality System Assist QA Manager in conducting major investigations (e.g. product complaints, recalls, returned goods, critical deviations) including review and evaluation of effectiveness of related Corrective Actions/Preventive ActionsAssist QA Manager in hosting regulatory inspections (FDA, HPFBI, PMDA etc) through ensuring pre-inspection preparation, coordinating inspection observation responses, and follow-upCoordinate and host external client audits through pre-audit preparations, audit observation responses, and follow-upExecute quality audits in support of external clients and vendor qualificationsMaintain current knowledge in QA, RA, auditing fields and disseminate to other QA staffProvide CGMP training and refresher trainingAct as a designate for Manager, Quality Manager in his/her absence or as requiredPerform other duties as assignedJOB REQUIREMENTS: B.Sc. in Chemistry or related scientific discipline with a minimum of 5 years experience or M.Sc. in Chemistry or related scientific discipline with a minimum of 2 years experienceSignificant experience in a in a Quality Assurance and/or Regulatory Affairs role within the pharmaceutical and/or API manufacturing industry. Experience in dealing with FDA, HPFBI, TPD and other international regulatory agencies. Experience in Regulatory Affairs and Analytical chemistry would be an asset. Proven skills and knowledge in co-ordinating and performing QA/RA activities (e.g. review of GMP documentation, assisting in client and regulatory audits, vendor audits)Extensive knowledge of FDA, USP and ICH regulations