To become the world's most valued company to patients, customers, colleagues, investors, business partners and the communities where we work and live. PfizerEngineering Compliance SpecialistTo become the world's most valued company to patients, customers, colleagues, investors, business partners and the communities where we work and live.Why PfizerVisit websitePfizer is one of the world's leading biopharmaceutical companies, with a portfolio of some of the world's most well known medicines, vaccines, and therapeutics. Every colleague who works at Pfizer plays an essential role in helping us fulfil our purpose of Breakthroughs that change patients' livesTM. Our purpose underpins everything that we do and reflects our passion for science and our commitment to patients.About the roleAs the Engineering Compliance Specialist, you will act as departmental SME for site quality systems (CAPA, Change Control, Compendial Assessments, Documentation Management, Annual Product Quality Review).CAPA & InvestigationsSupporting and managing CAPA process to drive an optimisation of CAPAs, investigations and other similar actions (inclusive of generation/analysis of KPIs).Provide technical support on investigations, CAPA actions and defining appropriate closure dates.Represent and advocate for Engineering Department in CAPA review forums and share outcomes to other engineering colleagues.Ensure the standard of Engineering Investigations and CAPAs are in line with regulatory requirements.Support central investigations team in the management of investigations as required.Change Control & DocumentationManage documentation periodic reviews for all engineering documentation and provide a central point of contact for documentation standards and requirements.Act as departmental system/process SME for change control. This will be through support engineering colleagues in the development, progression, management and execution of change controlsDevelop and manage the library of templates to support ease of use and standardization of documents across Engineering.Provide timely review of documentation change requests ensuring new and existing procedures are process mapped and impact assessed appropriately.Attend CCC to present Change Controls on behalf of Engineering (as required).Other Quality SystemsDepartmental primary contact for regulatory and internal audits and support the development/finalisation of observations responses.Responsible for the management of PQS/Regulatory change reviews for engineering systems.Ensures appropriate immediate actions are taken following quality/safety incidents to support compliant ongoing manufacture and/or product quality.Defines and implements CI strategies to improve effectiveness and efficiencies of processes.Act as departmental representative for Site Quality Review.Manage departmental APQR and compendium reviewsProvide support to the Engineering department and projects (as required)Support the delivery of inspection readiness programs associated with engineeringQUALIFICATIONSFormal qualification in Chemistry, Science or Engineering preferrable.Demonstrated knowledge of cGMP and Regulatory requirements for Australia, US and EMEADemonstrated experience in internal and external auditing processesExperience in deviation, CAPA and change control management within the pharmaceutical cGMP environment.Six Sigma Yellow/Green/Black Belt certification preferableWhat you'll be responsible forBackend application developmentDevelop, test, and maintain software applicationsSQL and DatabasesUse SQL to query databases to extract and process dataTest EngineeringCreate and implement code tests and software test automationSkills you'll needCollaborationWorks with others by being open, clear in communication and listening to achieve goalsNumerical problem solvingWorks with numerical information and performs mathematical calculations to solve problemsAttention to detailAccurately identifies and rectifies discrepancies or errors that exists in information and deliverables Be careful - Don't provide your bank or credit card details when applying for jobs. Don't transfer any money or complete suspicious online surveys. If you see something suspicious, report this job ad .
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