Senior python developer állások, munkák minőségbiztosítás kategóriában

• A gyógyszer-nagykereskedelem teljes körű minőségbiztosítási felügyelete, GDP/GMP megfelelőség biztosítása.
• 10-12 fős csapat irányítása (minőségbiztosítási munkatársak, felelős személyek, minőségbiztosítási vezető helyettes)

• 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

• 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.

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

EINFÜHRUNG We offer an exceptional opportunity for a professional seeking a challenging role in a renowned, fast-growing pharmaceutical company. Our client operates at the forefront of drug safety and pharmacovigilance, delivering high-quality scientific insights to support patient-focused risk...

SENIOR DATA SCIENTIST - LITERATURE (M/F/D)-INFORMATION SCIENCE/ PHARMACEUTICAL/ RESEARCH/ DEVELOPMENT/ PHARMACOVIGILANCE/ MEDICAL/ DRUG/ BIOMEDICAL/ SYNTHESIZE SCIENTIFIC DATA/ COMPETITOR INFORMATION ACCESS PLATFORM/ DIALOG/ ENGLISH PROJECT: For our pharmaceutical customer based in Basel, we are...

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

POSITION DESCRIPTION We are seeking an experienced and motivated professional to join our software quality assurance team. In this key role, you will help ensure compliance with IVDR, FDA 21 CFR Part 820, and cybersecurity requirements for medical device software. - Partner with development teams...

• Management of deviations, change requests as well as corrective actions and preventive actions
• Review of equipment qualifications, batch documentation, and product release preparations for clinical studies

TECHNICAL R&D ASSOCIATE SCIENTIST (M/F/D)- ANALYTICAL INSTRUMENTATION/ HPLC/ MS/ LC-MS/ OLIGONUCLEOTIDES/ ENGLISH PROJECT: For our pharmaceutical customer based in Basel, we are looking for a Technical R&D Associate Scientist (m/f/d) BACKGROUND: Behind each product in clinical trials or sold by...

• Start Date:or
• Latest Possible Start:
• Duration: 6 months initially; extension possible (e.g., additional 6 months)
• Location: Basel
• Workload: 100%
• Home Office: Yes
• Travel: Not expected
• Team Size: PCS safety team approx. 6; cross-functional project teamsmembers
• Hiring Manager: Simone Melega

Training Schedule Coordination: Collaborate with the Program Lead to define and maintain the annual training schedule....

• 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.

• 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.