Master Batch Record Designer
vor 7 Monaten
**COMPANY**
**ALTOGEN **is a Swiss engineering and consulting company specialized in life sciences with expertise in pharmaceuticals, biotechnology, medical devices.
With several years of experience, technical expertise and project coordination, we support our partners throughout all areas of the product life cycles.
We surround ourselves with junior to expert level consultants with strong development potential, whom we support in their professional goals.
To strengthen our team in **Switzerland**, we are looking for a **Master Batch Record Designer (M/F/X)** to start asap.
**ABOUT THE JOB**:
- Create, revise and maintain manufacturing and cleaning instructions (PAS-X) in cooperation with the producing departments and quality assurance
- Support in the training of MES/ MBR designers
- Create, revise and maintain manufacturing and cleaning instructions (PAS-X) in cooperation with the Production and Quality Assurance department
- Create / revise complex manufacturing regulations (MBR)
- Develop process requirements in close cooperation with the producing departments and clarify regulatory requirements with the Quality Assurance department
- Draw up / revise cleaning instructions (ESP)
- Review MBRs / ESPs for productive use
- Equipment management as well as creating and assigning status diagrams
- Initiate and control adjustments of MES-relevant SAP recipes
- Create, update MES-relevant SOPs
- Collaboration in continuous process improvement
- Carrying out PAS-X training courses
**ABOUT YOU**:
- You have academic degree(s) with focus in IT, Quality, Engineering or any other related field
- You have already worked in the pharmaceutical, biotech, chemical or similar industries
- Good GMP understanding with MES (PAS-X) knowledge and ERP (SAP) knowledge
- You have good analytical and synthesis skills as well as diligence and team spirit
- You are fluent in English and in German
**WHAT WE OFFER**:
- A permanent contract and innovative projects
- An attractive remuneration policy
- Personalized management and continuous learning to develop your career
- Great team spirt and an integration within the "Tribe"
**Job Type**: 100%
Schedule:
- Monday to Friday
Work Location: In person
-
Senior Quality Assurance Specialist
vor 2 Wochen
Basel, Basel-Stadt, Schweiz Gi Group SA VollzeitWe are seeking an experienced Senior Quality Assurance Specialist to join our team at Gi Group SA in the pharmaceutical industry.**Job Description:**The ideal candidate will have a strong background in quality assurance, with experience in implementing and maintaining quality processes, including review and approval of master batch records and executed batch...
-
Senior Quality Assurance Scientist
vor 4 Wochen
Basel, Basel-Stadt, Schweiz Gi Group SA VollzeitGi Group SA is a leading provider of recruitment services, and we are currently seeking a highly skilled Senior Quality Assurance Scientist to join our team.The ideal candidate will have a strong background in pharmaceutical manufacturing processes, particularly in biologic drug substance. They should be familiar with quality control procedures, including...
-
Batch Release Coordinator, QA Disposition
vor 2 Wochen
Basel, Schweiz Moderna Therapeutics Vollzeit**The Role**: The Batch Release Coordinator for the QA Disposition team will provide QA oversight and support of Moderna’s international organization’s product disposition of clinical and commercial product manufactured at contract manufacturing organizations (CMO) and tested at contract laboratory organizations (CLO). The Batch Release Coordinator will...
-
Lead Quality Assurance Specialist
Vor 6 Tagen
Basel, Basel-Stadt, Schweiz Gi Group SA VollzeitWe are seeking a highly skilled Lead Quality Assurance Specialist to join our team at Gi Group SA. This role will be responsible for implementing and maintaining quality processes, ensuring compliance with cGMP rules and regulations.Responsibilities:Implementation of Manufacturing Execution System (MES) with regards to QM processes, including 'Review by...
-
QA Manager
vor 7 Monaten
Basel, Schweiz Work Selection Vollzeit**Beschreibung**: For our international medical partner, F. Hoffmann-La Roche Ltd. in Basel, we are looking for a qualified and motivated **QA Manager** for a temporary contract of 18 months. **Tasks**: - Acts as a delegate of the Swiss RP for IMPs - Has the QA responsibility for GMP compliance of manufacture and analysis of IMP batches (in particular...
-
Quality Assurance Operations Specialist
vor 2 Wochen
Basel, Basel-Stadt, Schweiz Gi Group SA VollzeitWe are seeking a highly skilled Quality Assurance Operations Specialist to join our team at Gi Group SA.Job SummaryThe successful candidate will be responsible for implementing and maintaining quality processes, reviewing and releasing materials, and assisting with continuous improvement initiatives related to quality documents and...
-
Quality Assurance Manager
vor 7 Monaten
Basel, Schweiz Girardet Consulting AG VollzeitWagen Sie den nächsten Schritt in eine erfolgreiche berufliche Zukunft! Werden Sie Teil eines innovativen und hochspezialisierten Unternehmens in der pharmazeutischen Verpackungsindustrie im Basler Raum. Unser Kunde bietet Ihnen eine verantwortungsvolle Herausforderung und fördert Ihre berufliche Selbstverwirklichung. Es erwarten Sie vielseitige und...
-
Manager, Global Records
Vor 3 Tagen
Basel, Schweiz BeiGene VollzeitGeneral Description: - Responsible for ensuring that GCP records are handled and maintained to the required standards by maintaining awareness of current regulatory, legal, and other relevant guidelines. - Deliver on the strategy for Records Management within the TMF Management group ensuring the operational aspects are handled daily. - Oversee storage...
-
Record Manager Datenspeicher-systeme
vor 7 Monaten
Basel, Schweiz coni+partner AG Vollzeitconi + partner ist ein seit 1993 bestehendes Beratungshaus mit Sitz in Zürich und Niederlassungen in Düsseldorf und Shanghai. Unsere Stärke ist die passgenaue Besetzung von Positionen entsprechend der Unternehmenskultur, unter genauer Betrachtung fachlicher Kompetenzen, Referenzen und «soft skills» der Kandidaten. Unser Kunde ist eine Bank in Zürich....
-
Quality Assurance Senior Scientist
vor 1 Tag
Basel, Basel-Stadt, Schweiz Gi Group SA VollzeitAbout Gi Group SAGi Group SA is a reputable organization that seeks to fill a Quality Assurance Senior Scientist position.Job DescriptionThe Quality Assurance Senior Scientist will be responsible for implementing and maintaining quality processes, reviewing master batch records and executed batch records, and releasing purchased materials and internally...
-
Compliance Expert:in
vor 1 Monat
Basel, Schweiz Manpower VollzeitAufgaben und Verantwortlichkeiten: • Die Durchführung der Kontrolle auf Vollständigkeit und Richtigkeit der Eintragungen im Batch Record, Weitergabe der Batch Record Dokumentation an die QA nach Abschluss aller relevanten Tätigkeiten. • Verantwortlich für Compliance Themen im Wertstrom wie Quality Risk Management, SPOC Inspection Management,...
-
Senior QA Operations Specialist
vor 1 Woche
Basel, Basel-Stadt, Schweiz Gi Group SA VollzeitJob DescriptionWe are seeking a highly skilled Senior QA Operations Specialist to join our team at Gi Group SA.About the RoleThis is a key position responsible for ensuring the quality of our products and services. The successful candidate will be working closely with our manufacturing teams to implement Quality Management (QM) processes, including the...
-
Interior Designer
vor 5 Monaten
Basel, Schweiz Jet Aviation AG VollzeitAt Jet Aviation, we are not just in the business of aviation - we are in the business of (re)defining bespoke luxury. The artistry behind the art of flight. We are seeking a visionary Interior Designer to join our award-winning team, who thrives on creativity and innovation. If you are passionate about crafting extraordinary environments, that sets new...
-
Produktionsmitarbeiterin Pharmaindustrie
vor 7 Monaten
Basel, Schweiz ELAN Personal AG VollzeitRoche Schweiz schlägt die Brücke zwischen Pharmazie und Diagnostik. Wichtige Forschungs - und Entwicklungsfunktionen sind hier angesiedelt. Für unsere langjährige Kundin, die F. Hoffmann-La Roche AG in Basel, suchen wir eine/n **ProduktionsmitarbeiterIn Pharmaindustrie (m/w/d) 100%**: **Hintergrund**: Die Druckerei vom Global Investigational Product...
-
Quality Assurance Manager
vor 7 Monaten
Basel, Schweiz Panda Vollzeit**Quality Manager (f/m/d) 100%** A leading contract development and manufacturing partner (CDMO) for biotech and pharma customers is seeking a Quality Manager. The role involves commissioning, qualification, and process validation of a new manufacturing facility, as well as establishing the quality management system and processes to ensure compliance with...
-
Designer
Vor 3 Tagen
Basel, Schweiz DFINITY VollzeitThe Internet Computer is the fastest and only infinitely scalable general-purpose blockchain — incubated and launched by the DFINITY Foundation in May 2021. A team of over 200 world-renowned cryptographers, distributed systems engineers, and programming language experts have taken on the massive technological challenge of building, maintaining, and...
-
Qc Project Manager R&d
Vor 2 Tagen
Basel, Schweiz Regio Personal AG VollzeitREFERENZ 1415-100274-3-2 Unser Kunde engagiert sich mit viel Leidenschaft für seine Kunden aus der Welt der Pharma, Kosmetik und Technik. Für deren namhafte Marken ist unser Kunde führend in der Entwicklung und Herstellung von hochwertigen Produkten. Zur Verstärkung des QC-Teams wird per sofort oder nach Vereinbarung QC Project Manager R&D (m/w)...
-
Qc Project Manager
vor 1 Woche
Basel, Schweiz Girardet Consulting AG VollzeitFür unseren Kunden suchen wir zur Verstärkung des Teams einen QC Project Manager (m/w) für eine Festanstellung im Basler Raum zum nächst möglichen Termin. **Ihre Aufgaben**: - Mitarbeit in interdisziplinären Projektteams und Betreuung aller QC-Aspekte von der Akquise bis zur Markteinführung - Sicherstellen der Timelines und Bewahren des Überblicks...
-
Trainee Apparel Designer
vor 7 Monaten
Basel, Schweiz ODLO International VollzeitHünenberg **About ODLO**: ODLO engineers long lasting and largely sustainable technical apparel for active, passionate people. Simple as that. Outside or in. Fast or slow. From base layers and beyond. We're extremely proud to fuel the active lives of people in nearly 40 countries around the world. And to them we say, **keep going**. **Your field of...
-
Senior Quality Assurance Specialist
vor 4 Wochen
Basel, Basel-Stadt, Schweiz Gi Group SA VollzeitWe are seeking a highly skilled Senior Quality Assurance Specialist to join our team at Gi Group SA. As a key member of our quality assurance department, you will be responsible for ensuring the quality and compliance of our biologic manufacturing processes.**Job Summary**The Senior Quality Assurance Specialist will be responsible for implementing and...