Informatika állások, munkák minőségbiztosítás kategóriában

• Minősítésekhez használandó új eszközök bevezetése, validálási folyamatainak kialakítása
• Minősítésekhez használt eszközök IQ/OQ/PQ dokumentációjának készítése, validálások végrehajtása

• Vizsgálatra érkező minták kromatográfiás (HPLC) vizsgálata az érvényes külső és belső előírások szerint
• Anyagvizsgálatokhoz kapcsolódó teendők ellátása (oldatok készítése, mérőoldatok faktorozása)
• Vizsgálatok eredményéről a dokumentációk készítése (mérési jegyzőkönyvek vagy munkafüzetek)

• Develop, modify, and maintain quality evaluation and control systems for materials, in-process parts, and finished products.
• Translate product requirements/specifications into test plans, methods, and fixtures to ensure product reliability.

• Receipt / Download / Accepting of cases from Document Exchange Tool or electronically (or any other source)
• Translation of all relevant European Non-English information from source documents to English (if required) and updating relevant fields in Standard Adverse Event (AE) form

• Gondoskodik a nemzeti szabályozó hatóság által előírt követelményeknek való megfelelőségről a gyógyszer-nagykereskedelmi tevékenység során.
• Eljárásokat és dokumentumokat tart fenn az alkalmazandó szabályozási követelményeknek való megfelelőség biztosítása érdekében.

Acting as subject matter expert for global Quality applications (e.g. Veeva QualityDocs, Veeva QMS, LIMS and related systems), ensuring they remain compliant, user-centric, and fit for purpose....

• Lead the commercial development of profitable lab testing services
• Lead and develop the lab organization
• Monitoring of the laboratory and all work carried out there, to ensure compliance with relevant internal procedures and regulations

• Start Date: 16 February 2026
• Latest Possible Start Date: 16 March 2026
• Planned Duration: 12 months
• Extension: Very likely (approved budget)
• Location: Rotkreuz
• Workload: 100%
• Home Office: Yes, less than 50%
• Team Size: 28 people
• Department: Design Control Excellence CH (DSRSPC)

• Collaborate with cross-functional teams including IT, Quality Assurance, and Operations to ensure documentation and validation of systems according to internal procedures
• Ensure compliance with internal and external regulatory requirements and guidelines
• Maintain the inventory of software applications

• Lead and manage the site's full CAPEX portfolio, ensuring prioritization, regulatory compliance and alignment with corporate strategy.
• Lead, coach and develop a team of Project Managers and Controllers, ensuring effective resource planning and high performance.

Select and qualify packaging suppliers to ensure high-quality materials. Collaborate with suppliers to choose optimal packaging for Fresenius Kabi´s products....

QMS Process Management: Oversee the full lifecycle of changes for PTT owned QMS documents, from change initiation and action item assignment to responsible owners across the global network, driving completion and secure the final "approval to execute" before documentation is made effective...

• Create, edit, manage and modify all product and process documentation using PLM and ERP software packages.
• Be a part of the Manufacturing team with extensive interactions with the R&D and Quality departments.

Deliver technical expertise in the development of container closure systems, including vials, prefilled syringes, and prefilled cartridges, by employing cutting-edge methodologies to conduct comprehensive analyses and evaluations of their protection, safety, compatibility, and performance attributes...

Lead technical investigations for customer complaints and product CAPAs assigned to R&D, evaluate technical issues that occur during daily use of our systems in hospitals and act as key reference within the R&D team...

• Develop and implement global regulatory pathways for product authorizations
• Oversee preparation and submission of regulatory documents to authorities

• Batch record review for API and bulk product for monoclonal antibody prefilled syringes
• Assessment and documentation of product deviations, OOS, and changes
• Quality oversight for relevant service providers, including CMO's, laboratories, technical operations and supply chain

Lead and coordinate the Site-Launch activities and associated teams for internal and external sites and development projects...