QA Expert Compliance
vor 2 Wochen
Switzerland, BaselToday, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.
Key responsibilities:
- Drafts, negotiates and finalizes Quality Agreements with Suppliers and Service Providers
- Ensures the proper qualification of material/service suppliers by supervising adherence to global QMS requirements
- Interacts with the Global Supplier Qualification team by acting as local Point of Contact for the line units of Drug Product Services in both Basel and Stein
- Supports establishment and maintenance of the Quality Management System at Drug Product Services (DPS) for QC in Basel and manufacturing plants in Stein
- Prepares, reviews and approves GMP documents such as SOPs, Work Instructions for assigned topics
- Supports customer audits and health authority inspections as required
- Acts a system coordinator at local level for systems like DMS, Trackwise, SAP
Key requirements:
- Academic degree in Chemistry, Biochemistry, Pharmaceutical Sciences or related field
- Solid working experience in Quality Assurance in pharmaceutical industries and GMP controlled environment preferable in production and/or analytics. Experience with supplier qualification is a plus.
- Very good working knowledge in EU and US GMP regulations relevant for audit/inspections, qualification/validation, compliance systems
- Sound knowledge in compliance systems for document lifecycle management, training management and workflow tools (e.g. TrackWise)
- Ability to handle complex situations successfully, and to define tasks self-reliantly after discussion with line manager
- Highly organized work style to ensure multiple assigned projects can be handled in parallel
- Very good knowledge of written and spoken English; German is a plus
Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.
People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.
- Reference: R59609
-
QA Expert
Vor 2 Tagen
Basel, Schweiz Takeda Pharmaceutical Vollzeit**Takeda Neuchâtel** **Site de Production Biotech | Biotech Manufacturing Site** Takeda is an industry-leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do. We live our values of Takeda-ism - Integrity, Fairness, Honesty, and Perseverance - and are united by our mission to strive...
-
QA Expert
vor 3 Wochen
Basel, Basel-Stadt, Schweiz Lonza AG VollzeitSwitzerland, BaselToday, Lonza is a global leader in life sciences operating across three continents. While we work in science, there's no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big...
-
QA Expert Compliance
vor 3 Wochen
Basel, Schweiz Lonza VollzeitToday, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small,...
-
QA Computer Compliance Manager
Vor 7 Tagen
Basel, Schweiz Sobi Vollzeit**Company Description** At Sobi, each person brings their unique talents to work as a team and make a difference. We are dedicated to developing and delivering innovative therapies to improve the lives of people who live with a rare disease. Our edge comes from our team of people and our commitment to patients. Here at Sobi, our mission and culture get us...
-
Gmp Compliance Experte
vor 4 Wochen
Basel, Schweiz ITech Consult Vollzeit**GMP Compliance Experte (m/w/d)** **GMP Compliance Experte (m/w/d) -** **Änderungsprozesse /** **GMP /** **Deutsch / Qualitätssicherung / Zulassungsbehörden** **Projekt**: Für unseren Kunden, ein grosses Pharmaunternehmen mit Sitz in Basel suchen wir einen **GMP Compliance Experte (m/w/d)** **Hintergrund**: Als GMP Compliance Expertin / Experte im...
-
Compliance Experte
Vor 2 Tagen
Basel, Schweiz Work Selection Vollzeit**Beschreibung**: Wir suchen für unseren Kunden, F. Hoffmann-La Roche Ltd. mit Sitz in Basel, per sofort einen motivierten und engagierten **Compliance Expert** für einen befristeten Einsatz von einem Jahr mit Option auf Verlängerung. **Tätigkeiten**: - Koordination / Implementierung und Mitarbeit bei den Qualitätsprozessen (Änderungs-, Abweichungs-,...
-
Global QA/ra Manager
vor 4 Wochen
Basel, Schweiz Barrington James VollzeitBasel, Switzerland - 14-06-2023 - JOB TYPE - Permanent - EMP TYPE - Full-Time - EXPERTISE - Quality Assurance, Regulatory Affairs - SALARY TYPE - Annually - SALARY - Negotiable **Job Description: QA/RA Manager (Oncology Products)** **Position Overview**: We are seeking a highly skilled and experienced QA/RA Manager to join our pharmaceutical company based...
-
QA Expert
vor 3 Wochen
Basel, Schweiz Lonza VollzeitToday, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small,...
-
QA Expert
vor 3 Wochen
Basel, Schweiz Lonza VollzeitToday, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small,...
-
QA Expert Compliance
Vor 6 Tagen
Basel, Schweiz Lonza VollzeitSwitzerland, Basel - Switzerland, SteinToday, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their...
-
Cell & Gene Therapy Cmc Compliance Head (M/F) /d
Vor 7 Tagen
Basel, Schweiz Bayer Vollzeit**At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our...
-
Gmp Compliance Experte
vor 4 Wochen
Basel, Schweiz Coopers Group AG VollzeitGMP Compliance Experte Duration: unlimited **Ihre Aufgaben**: - Koordination / Implementierung und Mitarbeit bei den Abweichungs-, Change-, Risiko - und Änderungsprozessen Planned Event (PE) / Unplanned Event (UPE). - Unterstützung interner Kunden als anerkannter Berater in sämtlichen technischen GMP Fragestellungen, z.B. Dokumentation von PE / UPE. -...
-
Supply Chain QA Manager
Vor 2 Tagen
Basel, Schweiz Novartis Vollzeit2023 will see Sandoz become a standalone organization! As a global market leader in Generics and Biosimilar medicine, Sandoz is stepping forward from a position of strength! Those joining Sandoz in the coming months will help shape the future of the company, it’s growth, innovation, culture and how Sandoz impacts the lives of millions. These will be...
-
QA Associate
vor 4 Wochen
Basel, Schweiz Hobson Prior Vollzeit**Salary**: Negotiable**Job type**: Interim/Contract **Location**: Basel, Schweiz **Function**: Quality Assurance, Quality Systems **Posted**:18/04/2024 **Ref**: BBBH25158 - Hi I'm Jacob , I manage this role Please note that to be considered for this role you must have the right to work in this location. *** **Key Responsibilities** - Support a...
-
Gmp Compliance Experte 80-100%
vor 4 Wochen
Basel, Schweiz Work Selection Vollzeit**Beschreibung**: Wir suchen für unseren Kunden, F. Hoffmann-La Roche Ltd. mit Sitz in Basel, per sofort einen motivierten und engagierten **GMP Compliance Experte** für einen befristeten Einsatz von einem Jahr mit Option auf Verlängerung. Als GMP Compliance Expertin / Experte im Bereich GxP Compliance Fundamentals & Technical Standards, sind Sie im...
-
QA Manager
Vor 2 Tagen
Basel, Schweiz Manpower Vollzeit**Tasks & Responsibilities**: - 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 parenteral drug product batches). - Reviews and approves GMP procedures, records and reports (e.g. SOPs, master batch records, discrepancy and change records and validation...
-
QA Manager
vor 2 Wochen
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 12 months with a possible extension. The IMP Quality Operations Unit Switzerland in Global Technical Operations is the Quality partner for all Manufacturing Units and Clinical...
-
Gmp QA Coordinator
vor 4 Wochen
Basel, Schweiz CTC Resourcing Solutions Vollzeit**GMP QA Coordinator (5239 - ADA)** Our client, an innovative and dynamic bio-pharmaceutical company headquartered in Switzerland, covering multiple therapeutic areas, is looking for a **GMP Quality Assurance Coordinator** to join their Global Pharmaceutical Development Team. It is a **12-month contract**, with potential extension, based in...
-
Qc for QA Associate
Vor 6 Tagen
Basel, Schweiz BioTalent VollzeitBioTalent are uniting with a progressive & patient-focused partner for organisations within pharmaceutical and biotech spaces! The company supports the development and manufacturing of future medicines. They are searching for a **QC for QA associate** to join their world-class team in **Visp, Switzerland**! Target salary: CHF 100,000. **This role will...
-
QA Manager
Vor 6 Tagen
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...