Senior kontroller állások, munkák minőségbiztosítás kategóriában

• A minőségellenőrző laboratórium analitikai csoportjának szakmai vezetése és koordinálása.
• Analitikai vizsgálatok szervezése, irányítása és kiértékelése a GMP előírásoknak megfelelően.
• Dokumentációk naprakész vezetése és ellenőrzése.

• Execution of validation and testing activities according to quality requirements
• Validation and qualification of manufacturing and testing equipment
• Supporting the preparation of validation protocols, reports, and maintenance procedures
• Identifying and documenting potential process or equipment gaps

• Minőségügyi laboratórium vezetése, működés szakmai felügyelete; • Szervezeti egység irányítása, napi operatív támogatása, • Beérkező alapanyagok kezelésének, minősítésének, dokumentálásának koordinálása, • Termékminősítések fenntartása, új minősítésekre való felkészülés irányítása, • Termék...

• Központi nyilvántartás vezetése minden referencia- és munkastandard anyagról.
• Standardok beszerzésének, minősítésének és újraminősítésének koordinálása a hatályos szabványok és szabályozók szerint.
• Standardkezelési eljárások (SOP-ok) kidolgozása, karbantartása és betartatása.

• Responsible for processing incoming complaints in accordance with applicable process specifications
• Independent processing and assessment of complex or critical complaint cases with potentially high risk to patient safety or regulatory compliance

• Lead and inspire a global team of about 30 scientists and technical experts, fostering innovation, collaboration, and excellence.
• Spearhead the formulation and manufacturing process development for small molecule animal health products, from enabling formulations to tech transfer.

• Lead and oversee all clinical safety and vigilance processes for medical devices.
• Manage adverse event assessment and reporting in compliance with global regulations.
• Ensure accurate development and maintenance of RSI, CIP, and IB safety content.

• Master's degree in Life Sciences, Biology, Chemistry, Pharmacy, Engineering or Law
• Native German speaker with strong English skills (C1)
• 3+ years of experience in GMP deviation & CAPA management
• Strong IT skills

Medical Device Clinical Safety Scientist (m/f/d)- Healthcare/ Scientific/ Biomedical/ MDs/ MD Clinical Investigation/ CIP/ Protocol/ IB/ RSI/ Risk Management/ ISO/ Drug/ English PROJECT: For our customer a big pharmaceutical company in Basel, we are looking for a Medical Device Clinical Safety...

Provide expert leadership and oversight for all clinical safety and vigilance activities associated with Class II and/or III Medical Devices (MD), ensuring adherence to global regulatory requirements and internal standards throughout the product lifecycle....

• You are responsible for quality related topics like change control, deviations and/or complaints related to DS products at CMOs
• Define together with the CMO effective CAPAs and track the timely implementation

• Design, develop, and optimize coagulation diagnostic assays and reagents
• Lead feasibility studies, verification, and validation activities in compliance with ISOand IVDR requirements
• Document all activities according to quality system procedures and design control standards

Serve as the medical device subject matter expert to both internal and external customers for product development, risk assessment, training, implementation, literature reviews, complaints, safety signals, field action, voice of the customer, and voice of the business....

• Developing and maintaining sterility assurance and contamination control strategies for aseptic processing
• Leading risk assessments for aseptic process, single use systems and critical interventions, and ensuring compliance with authorities relevant Guidance such as Annex 1

• Collect data and prepare progress reports, KPIs, and metrics for regional and global reporting, including monthly reports, management reviews, and quarterly quality reports.
• Support ad hoc global quality reporting by gathering data and providing contextual insights to regional QA Senior Management.

• Interface between construction site and operator
• Support for the existing SHE organization (operator)
• Issuing work permits to contractors
• Monitoring compliance with relevant safety regulations
• Participation in coordination and construction meetings
• Safety inspections as needed