QA Specialist Serialization and Automation

pJobs / QA Specialist Serialization and Automation /p h3bQA Specialist Serialization and Automation /b /h3 pAt MindCapture you are not just starting a new role. You are joining a community that invests in your development and gives you the opportunity to grow in a meaningful technical career within healthcare. /p pYou can count on: /p ul liA competitive salary with a full benefits package including meal vouchers, eco vouchers, health insurance, group insurance, net expense allowance and a company car with charging or fuel card /li liPersonal growth support with tailored training and clear career development /li liA stable environment where your technical skills directly contribute to improved patient care /li liThe chance to work with high tech diagnostic systems at top tier healthcare institutions /li liA warm and collaborative culture focused on trust, ownership and long term impact /li /ul pAs QA Specialist Serialization and Automation, you will act as the global Quality representative for cross functional initiatives involving serialization systems and manufacturing automation. Your primary focus will be developing and deploying one harmonised set of global serialization procedures while ensuring alignment with international regulatory requirements. You will also assess Quality impact and define requirements for a new manufacturing automation integration approach. /p pbKey responsibilities /b /p ul liQuality leadership: Act as primary Quality contact for regulatory and compliance matters. /li liGlobal procedures: Develop consolidated serialization procedures and work instructions. /li liRegulatory translation: Convert global requirements into practical Quality controls and site procedures. /li liProcedure alignment: Ensure consistent implementation of global serialization requirements across sites. /li liTraining: Lead training and competency activities for Quality and operations teams. /li liAutomation support: Assess Quality impact of manufacturing automation integration activities. /li liQuality

requirements:
Define documentation and Quality expectations as automation projects progress. /li liChange management: Support change controls, risk assessments and procedural updates. /li liStakeholder alignment: Collaborate with Quality, IT, Regulatory Affairs, Operations and commercial stakeholders. /li /ul h3Required competences skills /h3 ul liExperience: At least eight years of Quality experience within pharmaceutical or biotechnology manufacturing. /li liSerialization: At least three years of experience with serialization or track and trace initiatives at global scale. /li liSOP expertise: Strong experience writing and implementing global GxP procedures. /li liRegulatory knowledge: Practical knowledge of European, United States and Chinese traceability requirements. /li liTechnical knowledge: Strong understanding of serialization systems and related Quality requirements. /li liAutomation: Experience with manufacturing automation is a plus. /li liData integrity: Knowledge of data integrity principles is a plus. /li liQuality systems: Strong skills in change control, risk assessment and procedural governance. /li liStakeholder management: Excellent influencing and collaboration skills across global functions. /li liEducation: Bachelor degree in pharmacy, life sciences, engineering or a comparable field. An advanced degree is a plus.br/ /li /ul pbQuality Compliance /b bBeerse /b bSenior /b bAt MindCapture as consultant /b /p h3About this application /h3 pThis opportunity is offered through MindCapture as a consultancy role with strong day to day ownership. You will be placed on site with our client. /p pMindCapture supports you throughout your assignment with clear onboarding, regular follow up and access to learning opportunities. You will have a dedicated point of contact, transparent communication and support to help you deliver impact in a structured way. /p h3Job Contact – Talent Business Team /h3 pOur Talent Business Managers combine a deep understanding of our clients’ needs with a sharp eye for talent. Their focus is on creating meaningful and sustainable matches, always keeping both the role and the candidate in mind. /p pWhen a potential match is identified, one of our TB colleagues may reach out to answer your questions, share additional context

about the role
and discuss possible next steps together, with clarity and transparency throughout the process. /p h3Explore other jobs in Quality Compliance /h3 ul liDrive CI through compliant lean quality practices /li liSupport strategic projects and ext quality operations /li liLead global quality alignment for serialization procedures /li liTranslate requirements into global quality processes /li liDefine quality requirements for automation integration /li liLead quality oversight for manufacturing validation activities /li liEnsure compliant validation across ext manufacturing /li liAct as validation expert during audits and submissions /li