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• Preparation of analytical evaluation protocols
• Data evaluation (internal / external performance data) by using statistical tools
• Preparation of performance study reports
• Support the post-marked performance follow-up process
• Support the creation of templates for Clinical Evidence requirements

• Ensuring compliance with applicable medical device software regulations and standards, including ISO 13485, ISO 14971, IEC 62304, IEC 62366 and IVDR
• Defining, maintaining, and governing software-related quality policies, procedures, SOPs, templates and lifecycle frameworks

Own advanced therapy workflows including Viral Vectors, Vaccines based on Viral Vectors, pDNA, exosomes, Synthetic DNA, mRNA, and Oligonucleotides, with a deep understanding of biological activity, development, and manufacturing processes....

QA Specialist Our client, headquartered in Baar, develops advanced diagnostics and therapies to improve patient outcomes. To support their growing team, we are looking for a versatile and motivated QA Specialist and Deputy RP (FvP/QP) to help shape a new and dynamic laboratory environment focused...

• Author and revise Standard Operating Procedures (SOPs) and quality system documentation in line with ISO 13485 and EU MDR 2017/745 requirements.
• Conduct GAP analyses of the QMS to identify compliance gaps and support continuous improvement activities.

The position as QC Bioassay Manager is responsible for leading a team of seven employees within the Quality Control department of AGC Biologics Heidelberg. This role entails the management and oversight of analytical testing of Bioassay Methods for Proteins and Nucleic Acids, including PCR, ELISA,...

Team Lead Visual Inspection (f/m/d) The actual location of this job is in Visp, Switzerland. Relocation assistance is available for eligible candidates and their families, if needed. As Team Lead Visual Inspection, you are primarily responsible for the personnel management and development of your...

• Conducting, documenting, and evaluating complex (bio)analytical and analytical methods for IPC, release, and stability testing
• Optimizing and qualifying/validating (bio)analytical methods in a QC/GMP environment following handover from the development departments
• Preparing GMP-compliant documentation

QA Specialist (f/m/d) - CSV & QV In Bern, we're not just expanding-we're reaching a major milestone by launching a new production site and introducing innovative ways of working. This is what being a Persistent Pioneer in our BN DNA is all about-bringing a pioneering spirit to everything we do....

Lead Expert Quality Assurance, Deputy Responsible Person 40% Become part of a vital chain and contribute to our common goal of making people’s lives better. Headquartered in Lachen, Switzerland, Octapharma is one of the largest human protein manufacturers in the world, developing and producing...

• Management of the QC department, including responsibility for budget and personnel
• Ensuring the timely QC testing of relevant materials (e.g., raw materials, intermediates, drug substances, finished drug products)
• Responsibility for method qualification/validation

Global Scientific Manager - IBU Critical Care Become part of a vital chain and contribute to our common goal of making people’s lives better. Headquartered in Lachen, Switzerland, Octapharma is one of the largest human protein manufacturers in the world, developing and producing medicines sourced...

• Own EU CMC regulatory strategy for assigned clinical-stage programs (phase I–III).
• Serve as regulatory partner to Quality and Technical Development, ensuring alignment while maintaining a risk-based regulatory perspective.