Engineering Compliance Specialist

vor 4 Wochen


Melbourne, Österreich Pfizer Vollzeit

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 SpecialistWhy PfizerPfizer 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 fulfill 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 controls.Develop 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 reviews.Provide support to the Engineering department and projects (as required).Support the delivery of inspection readiness programs associated with engineering.QUALIFICATIONSFormal qualification in Chemistry, Science or Engineering preferable.Demonstrated knowledge of cGMP and Regulatory requirements for Australia, US and EMEA.Demonstrated experience in internal and external auditing processes.Experience in deviation, CAPA and change control management within the pharmaceutical cGMP environment.Six Sigma Yellow/Green/Black Belt certification preferable.What you'll be responsible forBackend application development: Develop, test, and maintain software applications.SQL and Databases: Use SQL to query databases to extract and process data.Test Engineering: Create and implement code tests and software test automation.Skills you'll needCollaboration: Works with others by being open, clear in communication and listening to achieve goals.Numerical problem solving: Works with numerical information and performs mathematical calculations to solve problems.Attention to detail: Accurately identifies and rectifies discrepancies or errors that exist in information and deliverables.
#J-18808-Ljbffr



  • Melbourne, Österreich Pfizer Vollzeit

    This is a Engineering Compliance Specialist role with one of the leading companies in AU right now 🔥 -- Pfizer -- with an amazing team. They are continuing to grow rapidly. This is the chance to join right as the 🚀 takes off.More About the Role at Pfizer 🧐🧐As the Engineering Compliance Specialist, you will act as departmental SME for site quality...


  • Melbourne, Österreich Pfizer Vollzeit

    To become the world's most valued company to patients, customers, colleagues, investors, business partners and the communities where we work and live.Pfizer Engineering Compliance Specialist Why Pfizer Pfizer is one of the world's leading biopharmaceutical companies, with a portfolio of some of the world's most well-known medicines, vaccines, and...


  • Melbourne, Österreich Pfizer Vollzeit

    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 Specialist To become the world's most valued company to patients, customers, colleagues, investors, business partners and the communities where we work and live.Why PfizerVisit...


  • Melbourne, Österreich Pfizer Vollzeit

    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...


  • Melbourne, Österreich Pfizer Vollzeit

    ROLES & RESPONSIBILITIES As 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 & Investigations Supporting and managing CAPA process to drive an optimisation of CAPAs, investigations and other similar...


  • Melbourne, Österreich Pfizer, S.A. De C.V Vollzeit

    We're in relentless pursuit of breakthroughs that change patients' lives. We innovate every day to make the world a healthier place.To fully realize Pfizer's purpose – Breakthroughs that change patients' lives – we have established a clear set of expectations regarding "what" we need to achieve for patients and "how" we will go about achieving those...


  • Melbourne, Österreich Tideri Jobbörse Vollzeit

    We're in relentless pursuit of breakthroughs that change patients' lives.We innovate every day to make the world a healthier place.To fully realize Pfizer's purpose – Breakthroughs that change patients' lives – we have established a clear set of expectations regarding "what" we need to achieve for patients and "how" we will go about achieving those...


  • Melbourne, Österreich Talent International Vollzeit

    Job Title: Engineering Support Specialist Location: Williamstown, NSW Clearance Required: NV1 Job Description: Our client is seeking a skilled Support Engineer to join their team.This position involves handling a variety of engineering tasks with minimal direction while collaborating with individuals across all levels of the organization. Key...


  • Melbourne, Österreich Https:Www.Energyjobline.ComSitemap.Xml Vollzeit

    Job Title: Engineering Support Specialist Location: Williamstown, NSW Clearance Required: NV1 Job Description: Our client is seeking a skilled Support Engineer to join their team.This position involves handling a variety of engineering tasks with minimal direction while collaborating with individuals across all levels of the organization. Key...

  • Engineering Manager

    vor 1 Woche


    Melbourne, Österreich Engineering Personnel Vollzeit

    Excellent working environment with opportunities for career advancement.Join a reputable and trusted Australian industry leader.Competitive and attractive remuneration package with sponsorship available.Position:Engineering ManagerLocation:New South Wales, AustraliaSalary:Approximately $170,000 plus SuperannuationVisa Sponsorship:Available for qualified...

  • Compliance Specialist

    vor 2 Wochen


    Melbourne, Österreich Steadfast Group Vollzeit

    Steadfast Group is the largest general insurance broker network and the largest underwriting agency group in Australasia with growing operations internationally.We were founded on the belief that a network of brokers would be stronger together, and this idea has been the backbone of our culture ever since.We believe that none of us is as good as all of us.At...

  • Compliance Specialist

    vor 2 Wochen


    Melbourne, Österreich Steadfast Group Limited Vollzeit

    Steadfast Group is the largest general insurance broker network and the largest underwriting agency group in Australasia with growing operations internationally. We were founded on the belief that a network of brokers would be stronger together, and this idea has been the backbone of our culture ever since. We believe that none of us is as good as all of...


  • Melbourne, Österreich Twoscots Recruitment Vollzeit

    We are seeking a Payroll Compliance Specialist to ensure accurate, compliant, and efficient payroll processes across a complex organizational structure.About the Role: This role is focused on managing payroll compliance, governance, and accuracy while adhering to relevant legislation, company policies, and best practices.You'll work closely with stakeholders...

  • Compliance Specialist

    vor 2 Wochen


    Melbourne, Österreich Steadfast Group Limited Vollzeit

    Steadfast Group is the largest general insurance broker network and the largest underwriting agency group in Australasia with growing operations internationally.We were founded on the belief that a network of brokers would be stronger together, and this idea has been the backbone of our culture ever since.We believe that none of us is as good as all of us....

  • Compliance Specialist

    vor 4 Wochen


    Melbourne, Österreich Pepperstone Vollzeit

    The Pepperstone story started in 2010.We know what it's like to trade the world's markets.Our team describes us as a place for the curious and the driven, and we like to do things a little differently; as a transformative global fintech we're digital, nimble, connected, and united in our vision to create a better way to trade.We thrive on progress – for...

  • Compliance Specialist

    vor 4 Wochen


    Melbourne, Österreich Pepperstone Vollzeit

    The Pepperstone story started in 2010.We know what it's like to trade the world's markets.Our team describes us as a place for the curious and the driven, and we like to do things a little differently; as a transformative global fintech we're digital, nimble, connected, and united in our vision to create a better way to trade.We thrive on progress – for...


  • Melbourne, Österreich Buscojobs Vollzeit

    Policy, Planning & Regulation (Government & Defence)Full time L3Harris Technologies is an agile global aerospace and defence technology innovator, delivering end-to-end solutions that meet customers' mission-critical needs.We provide advanced defence and commercial technologies across the air, land, sea, space and cyber domains.L3Harris Australia (operating...

  • Compliance Specialist

    vor 1 Monat


    Melbourne, Österreich Pepperstone Eu Limited Vollzeit

    The Pepperstone story started in 2010. We know what it's like to trade the world's markets. Our team describes us as a place for the curious and the driven, and we like to do things a little differently; as a transformative global fintech we're digital, nimble, connected, and united in our vision to create a better way to trade.We thrive on progress – for...

  • Compliance Specialist

    vor 1 Monat


    Melbourne, Österreich Pepperstone Eu Limited Vollzeit

    The Pepperstone story started in 2010.We know what it's like to trade the world's markets.Our team describes us as a place for the curious and the driven, and we like to do things a little differently; as a transformative global fintech we're digital, nimble, connected, and united in our vision to create a better way to trade.We thrive on progress – for...

  • Compliance Specialist

    vor 1 Monat


    Melbourne, Österreich Tideri Jobbörse Vollzeit

    The Pepperstone story started in 2010.We know what it's like to trade the world's markets.Our team describes us as a place for the curious and the driven, and we like to do things a little differently; as a transformative global fintech we're digital, nimble, connected, and united in our vision to create a better way to trade.We thrive on progress – for...