Einleitung

Die We make it GmbH ist ein national tätiges Unternehmen in der Schweiz, das dank langjähriger erfolgreicher Erfahrung über eine hohe Kompetenz im Bereich der Personaldienstleistungen verfügt. Die Rekrutierungsaktivitäten sind auf die Kernbereiche Industrie, Technik, Büro/Verwaltung, Engineering, Pharma und IT fokussiert. Die We make it GmbH stellt höchste Ansprüche an Qualität, Ethik und Diskretion.

Quality Assurance Associate

CSL Behring AG in Bern specializes in the manufacture of drugs for the treatment of immune deficiencies and immune dysfunction, as well as drugs for rhesus prophylaxis and albumin solutions for shock and burn victims. CSL Behring AG's production facilities are licensed by the Swiss health authorities and the US FDA. Every year, therapeutically important proteins are isolated from over six million liters of human plasma in accordance with the strictest safety and quality standards and processed into medicines. The products of CSL Behring AG are distributed worldwide.

This role is responsible for all routine and non-routine quality oversight activities in collaboration with the operational organizational units of on local Maintenance & Utilities, Quality Control, local warehouse and internal transports and qualification activities in Opex projects as well as periodic Requalification activities. This includes operational quality management according to cGMP to assure appropriate quality of the services provided to the Value Streams, adherence to any applicable CSL standards and procedures, review and approval of related complex GxP records, support and approval of complex quality risk assessments, non-conformances, investigations, CAPAs, change controls and is aware of the corresponding quality performance metrics and provides improvement for them. Project management and project realization in complex cross functional and also global projects. Subject Matter Expert for complex deviations and changes during inspections and audits. Acts also globally with other QA Support Functions units.

Aufgaben

You are required to comply with all safety guidelines and regulations, use safety equipment correctly, and attend safety training, Where prescribed and required, wear protective equipment consistently and replace when defective, You are responsible for eliminating hazards and risks immediately where possible, otherwise report them to your supervisor immediately, With your behavior, you contribute to the achievement of our safety goals and actively contribute to improvements in our safety and our safety culture, You are responsible for the safety of your employees and for the technical occupational safety incl. instruction, training, preparation of work regulations and further training in your area. You ensure compliance with all safety guidelines and regulations at all times, You play a proactive role in investigating accidents and near misses and implementing measures supported by the safety officers (SiBe) in your area, You ensure that your safety officers can perform their duties, You contribute as a role model to the improvement of safety and safety culture, You ensure that the defined safety targets are integrated into their employees' work plans in a level appropriate manner and are committed to achieving the targets, You encourage your employees and safety officers to get involved in the continuous improvement of our safety and safety culture, Follow the decisions and instructions of the “Dotted Line” superior in relation to GMP/GDP relevant aspects at the site, Integration in the management systems of the “Dotted Line” function, i.e. participation in the relevant leadership bodies and reporting within the own area of responsibility, In alignment with the direct and the “Dotted Line” superior, authority to give directions within the own area of responsibility at the site, General duties, Operational duties, Live CSL Values, Contribute to and facilitate team spirit, Further personal development (courses, literature study etc.), Ensures compliance with GMP regulations at all times, Maintains a broad view on the whole process, Nurture efficient Communication Regularly inform superior about current business as well as problems within unit, Ensure that colleagues, as well as customers receive the appropriate and required information at all times, Partnering and influencing relevant stakeholders in maintenance, utilities engineering, quality control and local warehouse to maintain compliance and adhere to QA standards. Accomplishes binding agreements and decisions with the stakeholders in business relevant issues, Ensures Quality Assurance oversight and drives quality decisions jointly with the stakeholders in the areas of maintenance / utilities, utility monitoring, material management, warehousing, and quality control to maintain compliance in the specified areas, Periodic quality floor tours in warehouse with warehouse supervisor and Supply Chain with regard to improvement, exception handling and quality decisions (material usage decisions), Drives evaluation and implementation of new Quality on the Floor activities, Management of deviations as “Assigned to” Quality function for minor, major and critical deviations with profound capability to efficiently isolate GMP relevant key indices incl. lead of team to performing initial risk assessments, Quality on the Floor oversight of the investigation, jointly generation of deviation reports with the owner to ensure compliance, establishing root cause and defining CAPAs. QA approval/closing of deviations, effective CAPAs and recurrence investigations support, Manages independently and proactively complex and cross-functional local and cross-site deviations, Actively drives reduction of recurrence by proposing efficient sustainable CAPAs, Assesses excursions during transport of analytical samples and decides about use (compliance decision), Assesses transport damages of transport to affiliates / in affiliates warehouse and makes decision about use of materials based on Global Logistics Quality requests, Second approval of deviations, Management of changes as “Quality Delegate” function with profound capability to efficiently isolate GMP relevant key indices incl. support of the coordinator of changes, initial classification of changes, oversight of assessments and actions, inform customers, participate in Change Control Panel, approval of changes, QA approval of actions, assess change status and ensure all activities to be compliant to set change into “Release to Implementation (RTI) or “Release to Operation” /RTO) and close change when completed on a timely manner, Manages independently complex, major, cross-functional and cross-site change requests, Participates in Global Change Panel for major changes, QASF assessment of changes, Raw materials: Review and completion of APR/PQR regarding raw material data. Review for trending and clusters for rejected lots, Raw materials: Decision if a new raw material is subject to testing, Reviews and provides QA approval for GxP documentation in the specified areas of duty, including complex documents e.g. QA representative in complex team risk analyses, Responsible for defining review criteria for non-routine documents, formats in development and QA decision, Leads periodic “Tier 1” meetings of QA SF and other functions (QC, M2U, Warehouse) and maintains good communication and exchange of all GxP activities on a periodic basis in the QA Support, Functions team, Is aware of relevant KPIs which relate to activities of QA Support Functions, Leads cross functional Tier 1 meetings in areas of responsibility (QC, warehouse, M2U), Participates in meetings with global units e.g. QC Excellence, Participants cross functional Tier 2 meetings in areas of responsibility, Participates in global QA SF meetings and workshops, Coordinates and performs qualifications of new employees in GMP training in QA Support Functions and other Quality units, Develop new QA SF and cross-functional qualifications and concepts, Prepares and presents independently quality investigations and changes to health authorities in area of duty, Hosts authority inspections, Topic Manager and Subject Matter Expert for authority requests, Proposals and implements system improvements in QA Support, Functions and areas of duty, Designated operational support of QA systems, testing of new versions, improvements, etc. (e.g. Veeva), Data generation and evaluation for e.g KPIs, elaborates decision basis, QA lead in large complex cross functional and global projects, May be responsible for providing guidance, coaching and training to other employees within job area

Qualifikation

8 years or more working in a similar role with demonstrated independent way of working and self-driven learning ability

Profund expertise in cGMP and Compliance, Engineering maintenance operations, Utility monitoring programs,

Material management and warehousing & logistics, Quality control & analytical methods, Change control management, Deviation management, CAPA management

Collaboration skills

Mentoring / coaching of colleagues in domain of expertise

Strong ability to network across departments to liaise for efficient collaborations

Capability to communicate technical matters in an understandable, concise and precise form

Strong communication, influencing, and presentation skills

Noch ein paar Worte zum Schluss

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