freiberufler Swiss Quality and Process Services (SQPS®) auf freelance.de

Swiss Quality and Process Services (SQPS®)

zuletzt online vor wenigen Stunden
  • 135€/Stunde
  • 4058 Basel
  • Nähe des Wohnortes
  • de  |  en  |  fr
  • 20.10.2026
  • Contract ready

Kurzvorstellung

Seit 2014 unterstütze ich mit SQPS® kleine und mittlere Unternehmen sowie größere Organisationen bei Qualitäts-Compliance, Prozessverbesserung und Validierungsprojekten. Besonders gefragt bin ich, wenn Engpässe überbrückt oder spezielle Fragestellung

Geschäftsdaten

 Gewerbetreibend
 Steuernummer bekannt
 Berufshaftpflichtversicherung aktiv

Qualifikationen

  • Controller
  • Deviation/CAPA
  • GMP
  • inspection
  • Pharmakologie
  • vmp

Projekt‐ & Berufserfahrung

Intelligent document processing engine (OCR and computer vision) (Issam Hadjallah)
Information technology / GenAI software, remote
8/2025 – 12/2026 (1 Jahr, 5 Monate)
Information technology / GenAI software
Tätigkeitszeitraum

8/2025 – 12/2026

Tätigkeitsbeschreibung

Architected the AI pipeline at the core of the SQPS document-processing product. It turns scanned paper and PDF batches into organised, searchable documents using image pre-processing, OCR and layout analysis, served through a FastAPI backend. I also built models that split multi-document scans and classify each document by type, plus an LLM-based extraction system for rule-based file naming.

Eingesetzte Qualifikationen

Langchain, Opencv, Python

Machine Learning Engineer – High-Performance Inference Systems (Mohanned Kadache)
Information technology / Software, Remote
12/2023 – 12/2026 (3 Jahre, 1 Monat)
Information technology / Software
Tätigkeitszeitraum

12/2023 – 12/2026

Tätigkeitsbeschreibung

Built the web application end to end, from the TypeScript frontend to the FastAPI backend and REST APIs. Users upload files, track progress and download results. I used Celery/Redis job queues for heavy AI workloads, WebSockets for real-time status, PostgreSQL with role-based, per-organisation data separation, JWT/OAuth security, and Docker for deployment.

Eingesetzte Qualifikationen

Python-Programmierer, Docker, Typescript

QA Lead Single Use project; QA-SME Clean Rooms (site-wide)
Multinational mAb CMO near Bern, Switzerland / Bern region
12/2023 – 12/2026 (3 Jahre, 1 Monat)
Pharmaceuticals / Biotechnology (multinational mAb CMO)
Tätigkeitszeitraum

12/2023 – 12/2026

Tätigkeitsbeschreibung

QA lead for a single-use project and site-wide QA subject matter expert for clean rooms. I gave strategic guidance on CQV aspects and embedded them in the QMS. I reviewed and approved plans, reports, deviations, CAPAs, change controls and the VMP, prepared inspection readiness, and mentored junior QA colleagues.

Eingesetzte Qualifikationen

Qualitätskontrolleur Apotheke, Inspektor (Sonstige)

Generative AI Engineer – RAG & LLM Systems (Yasmina Medjri )
Brenco Engineering & Consulting, Remote
7/2023 – 10/2024 (1 Jahr, 4 Monate)
Information technology / Telecommunications & electronics
Tätigkeitszeitraum

7/2023 – 10/2024

Tätigkeitsbeschreibung

Architected and deployed an end-to-end generative AI platform leveraging LLaMA foundation models and Retrieval-Augmented Generation (RAG) to generate personalized social media content at scale.
Performed LLM fine-tuning using advanced techniques to adapt the model for domain-specific content generation.
Implemented comprehensive RAG pipeline integrating ChromaDB and FAISS vector databases for efficient semantic search and context retrieval.
Built production-ready Flask APIs with full MLOps infrastructure including Docker containerization, Gunicorn WSGI server, Redis caching, and Nginx reverse proxy.
Conducted thorough testing, documentation, and system validation, ensuring platform reliability and maintainability.
Demonstrated ability to deliver complex AI systems from research concept through production deployment, collaborating effectively with business stakeholders.

Eingesetzte Qualifikationen

Programmierer (Sonstige), Python-Programmierer

Interim Head Quality Third Parties
(mRNA company), Germany / Tübingen region
12/2022 – 12/2023 (1 Jahr, 1 Monat)
Chemieindustrie
Tätigkeitszeitraum

12/2022 – 12/2023

Tätigkeitsbeschreibung

Interim head of third-party quality. I consulted on improving the QMS to create a lean, compliant third-party qualification and notification process. I prepared inspection readiness with the main CMO, clients and partners, trained colleagues, and secured resources to improve the systems.

Eingesetzte Qualifikationen

Lieferantenanalyse, Helpdesk-Mitarbeiter (Third Level), Qualitätsprüfung

QA Lead Qualification, biopharmaceutical plant extension
Kundenname anonymisiert, Zermatt region
11/2021 – 12/2023 (2 Jahre, 2 Monate)
Pharmaceuticals / Biopharmaceuticals
Tätigkeitszeitraum

11/2021 – 12/2023

Tätigkeitsbeschreibung

Responsible for strategic QA matters and QA oversight on a CHF/EUR 350 million plant extension. I reviewed and approved qualification documents per the ISPE guide 2019, onboarded junior QA managers, passed a Swissmedic inspection and established FDA inspection readiness.

Eingesetzte Qualifikationen

Pharma / Kosmetik

DSM team: CSV and commissioning, biopharmaceutical project
Kundenname anonymisiert, Vienna region
1/2020 – 12/2021 (2 Jahre)
Pharmaceuticals / Biopharmaceuticals
Tätigkeitszeitraum

1/2020 – 12/2021

Tätigkeitsbeschreibung

Supported technical commissioning of downstream equipment, performed software validation (CSV) of an automated SCADA system, documented IQ/OQ, and led clean-media qualification for the downstream plant.
Qualifications: CSV, GAMP 5, 21 CFR Part 11, SCADA, IQ/OQ, commissioning

Eingesetzte Qualifikationen

Pharma / Kosmetik

Team Lead Validation (interim)
Kundenname anonymisiert, Basel region
11/2019 – 5/2020 (7 Monate)
Pharmaceuticals
Tätigkeitszeitraum

11/2019 – 5/2020

Tätigkeitsbeschreibung

Interim team lead covering a parental leave. I coordinated annual re-validations with production and engineering, and handled CIP cycle development, cleaning validation, hold-time validation, process validation and thermal process validation. I also contributed to deviation investigations, CAPA implementation and investment projects.

Eingesetzte Qualifikationen

Pharma / Kosmetik, Medienwissenschaft, Wärmeisolierer / Kälteisolierer

Über mich

Service Focus Areas
End-to-End Process & Quality Assurance for Biotechnology: QA and validation from clinical development through commercial manufacturing, combining regulatory expertise with project management.
GxP Excel Spreadsheet Validation: validation of GxP-critical calculations and data processing, meeting requirements for data integrity, patient safety and product quality.
AI-Driven QMS Generation & CQV Project Documentation: automated generation and lifecycle management of QMS and CQV (Commissioning, Qualification, Validation) documentation.
QHSE (Quality, Health, Safety & Environment): support in implementing best practices, ensuring compliance and fostering a safe, sustainable working environment.

Weitere Kenntnisse

Skills / Keywords (for search)

Quality Assurance (QA), Quality Management System (QMS), GxP, GMP, Validation, Process Validation, CQV, Computer System Validation, Excel Validation, Data Integrity, Biotechnology, Pharma, Process Improvement, Operational Excellence, QHSE, Compliance, Project Management, AI-assisted Documentation

Add the specific standards and regulations you actually work with (e.g. ISO 9001, ISO 13485, EU GMP Annex 11, FDA 21 CFR Part 11, GAMP 5), but only those you can back up.

Persönliche Daten

Sprache
  • Deutsch (Muttersprache)
  • Englisch (Fließend)
  • Französisch (Fließend)
Reisebereitschaft
Nähe des Wohnortes
Arbeitserlaubnis
  • Schweiz
Home-Office
unbedingt
Profilaufrufe
14
Alter
45
Berufserfahrung
11 Jahre und 6 Monate (seit 04/2015)
Projektleitung
11 Jahre

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