QA Computer Compliance Manager

Vor 7 Tagen

Basel, Basel-Stadt, Schweiz Sobi Vollzeit

Sobi offers the opportunity to work at an international pharmaceutical company focused on specialty pharmaceuticals meeting the high medical needs of rare disease patients and providing treatment and services to them. Our employees come from a variety of backgrounds within research, healthcare, industry and the academic sphere.

QA Computer Compliance Manager:

Role & Function

The position is situated in our Quality function in Switzerland, where you will be part of a team consisting of highly professional people, who work hard and have fun on the way.

Sobi has embarked on a journey to become a Global Leader within Rare diseases. Digital solutions are an integral and important building block in this journey. As QA Specialist your goal is to deliver support and advice regarding GxP regulated computerized systems. You will have a role interfacing with all parts of the Sobi organization.

Key Responsibilities

  • QA support to line of business for computerized systems with focus on manufacturing and laboratory systems) e.g. review and approve quality related documentations such as SOP's, specifications, validation/qualification documents, periodic reviews, change requests, CAPAs, deviations etc.
  • QA Project Support involving computerized systems, data transfer, IT related topics.
  • Drive and take responsibility for improvement projects as applicable.
  • Contributing to the ongoing maintenance and optimizing the routines for computerized system e.g. updating templates, system list, VMP and follow up the periodic review of the systems.
  • Contributing to the ongoing maintenance and optimizing of Sobi ́s Quality System.
  • Support authority inspections and partner audits from computer compliance point of view.
  • Lead or participation in external audits of suppliers and supplier evaluations could be included in the responsibilities depending on your background and ambition.
  • Additionally, you will participate in various projects across the entire organization and with many different stakeholders.
    Qualifications
  • Probably you hold an Engineering or a Master ́s degree in IT or Life science combined with some years of experience working in a Quality role in a GxP regulated environment (e.g. CFR Part 11, EU GMP VOLUME 4 (Annex Preferably you have a background working in a similar role as QA for computerized systems or from being validation/system responsible, you can also work in a quality role within IS/IT.
  • The position is also open for applicants with a background as QA from the pharma/medical device industry and the motivation to further develop their skills within QA for computerized systems.
  • Professional level of English is a must.
  • Data Integrity and GAMP is a plus.
  • Auditor training and/or knowledge of supplier management is also a plus but is not required.
    Personal attributes
As a person you can work independently and have an ambitious mindset. You are proactive, service minded and a profound team player. Furthermore, you possess excellent communication skills.

In addition, you must demonstrate behaviors in line with Sobi's core values:
Care, Ambition, Urgency, Ownership and Partnership.

Location
The position will be based in Basel, Switzerland.

Reporting to
Head of GxP Process Excellence Head.

**Sobi is an affirmative action and equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, disability, age, sexual orientation, gender identity, or national origin. Sobi is committed to providing access, equal opportunity and reasonable accommodation for individuals with disabilities in employment, its services, programs and activities.

  • QA Computer Compliance Manager

    Vor 7 Tagen

    Basel, Basel-Stadt, Schweiz Sobi Vollzeit

    Company DescriptionAt 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 excited...

  • QA Manager

    Vor 7 Tagen

    Basel, Basel-Stadt, Schweiz Panda International Vollzeit

    QA Manager - CMO - Basel - Zurich:Location Basel, SwitzerlandBusiness Sector BiotechnologyJob ref 22212Published 11 days agoQuality Assurance Manager - SwitzerlandAre you an experienced QA professional in Biotech? Join our client in Northern Switzerland, a prominent leader in cell & gene therapy. As a Senior QA Manager, you'll play an important role in...

  • QA Manager

    Vor 7 Tagen

    Basel, Basel-Stadt, Schweiz PC Basel Vollzeit

    Anstellungsart » PensumTemporär » VollzeitSektor » BerufsgruppeIndustrie / Produktion » Pharma / ChemieUnternehmens-GrösseGross (> 250 Mitarbeiter)Unternehmens-TypmodernUnternehmens-FührungklassischPersonal Contact vermittelt und verleiht seit über 25 Jahren erfolgreich qualifiziertes Personal in den Bereichen Industrie, Pharma, Technik und...

  • Technical QA Manager

    Vor 7 Tagen

    Basel, Basel-Stadt, Schweiz Randstad Vollzeit

    Job DescriptionOur client, an international pharmaceutical company in Basel, is seeking a Technical QA Manager to ensure cGMP compliance and maintain operational standards at the Swiss Technical R&D sites. The ideal candidate will have over 5 years of QA experience, with expertise in Qualification/Validation of Small Molecules, Analytics, and...

  • QA Manager

    Vor 7 Tagen

    Basel, Basel-Stadt, Schweiz Personal Contact Basel AG Vollzeit

    Personal Contact vermittelt und verleiht seit über 25 Jahren erfolgreich qualifiziertes Personal in den Bereichen Industrie, Pharma, Technik und Gewerbe.Mit Fachkompetenz, Menschlichkeit und Engagement bietet Personal Contact lückenlose Dienstleistungen an, welche den höchsten qualitativen Ansprüchen des Personalwesens entsprechen.Für unseren Kunden,...

  • QA Manager

    Vor 7 Tagen

    Basel, Basel-Stadt, Schweiz ITech Consult AG Vollzeit

    QA Manager - GMP / Quality Risk Management / Qualification / Validation/ Parenterals / English & GermanDescription:The IMP Quality Operations Unit Switzerland in Global Technical Operations is the Quality partner for all Manufacturing Units and Clinical Packaging in Pharmaceutical Technical Development in Switzerland. They are responsible for the Quality,...

  • QA Expert Compliance

    Vor 7 Tagen

    Basel, Basel-Stadt, Schweiz Lonza Vollzeit

    Today, 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,...

  • Third Party QA Manager Api

    Vor 7 Tagen

    Basel, Basel-Stadt, Schweiz Elanco Vollzeit

    Education :EQUIVALENTEXPERIENCEAs a leading global animal health company, Elanco delivers innovative products and services to improve the health of pets and farm animals around the world because we believe making animals' lives better, makes life better. Since 1954, we have provided solutions that support veterinarians, farmers and pet owners to advance our...

  • Technical QA Manager

    Vor 7 Tagen

    Basel, Basel-Stadt, Schweiz ITech Consult AG Vollzeit

    Technical QA Manager (m/f/d) - Quality Management / Qualification/Validation / CSV of Small Molecules / Data Integrity / GMP/IMP/ English & GermanProject: For our customer a big pharmaceutical company in Basel we are looking for a highly qualified Technical QA Manager (m/f/d).Background:The IMP Quality Operations Unit Switzerland in Global Technical...

  • QA Expert

    Vor 7 Tagen

    Basel, Basel-Stadt, Schweiz CTC Resourcing Solutions Vollzeit

    QA Expert - Drug Development ADAOur client, an innovative and dynamic bio-pharmaceutical company headquartered in Switzerland, covering multiple therapeutic areas, committed into delivering products on the market over the next 5 years, is looking for a QA Expert - Drug Development for 1 year contract with high possibility of extension based in Basel,...

  • QA Manager

    Vor 7 Tagen

    Basel, Basel-Stadt, Schweiz unisite ag Vollzeit

    Die unisite ag ist ein Dienstleister im Bereich Employer Branding & Talent Management. Wir beraten Kunden aus den Bereichen Chemie, Pharma, Biotech, Medical Device & Life Sciences.Unser Kunde, Boehringer Ingelheim Schweiz in Basel, hat das Ziel die Gesundheit und die Lebensqualität von Patienten zu verbessern. Seit der Gründung im Jahre 1885 in...

  • Technical Qa Manager

    Vor 7 Tagen

    Basel, Basel-Stadt, Schweiz Kelly Services (Schweiz) AG Vollzeit

    For the pharmaceutical company F. Hoffmann-La Roche, we are seeking a Technical QA Manager for a temporary 100% position. Join our team!About the RoleThe IMP Quality Operations Unit in Global Technical Operations handles the Quality oversight of all Investigational Medicinal Products (IMPs) for clinical studies in Switzerland. As the Technical QA Manager,...

  • Release QA Manager, Quality Assurance Disposition

    Vor 7 Tagen

    Basel, Basel-Stadt, Schweiz Moderna Therapeutics Vollzeit

    The Role:The Release QA Manager for Moderna's International Organization will support the product release (including market release) for International markets (EU and ROW) as well as wholesale distribution to these countries. He/she will work closely with the EU QPs to support EU batch certification of products and cross-functionally to create and maintain...

  • Technical QA Manager

    Vor 7 Tagen

    Basel, Basel-Stadt, Schweiz Kelly Services (Schweiz) AG Vollzeit

    For a big pharmaceutical company in Basel we are looking for a Technical QA Manager Background:The IMP Quality Operations Unit Switzerland in Global Technical Operations is the Quality partner for all Manufacturing Units and Clinical Packaging in Pharmaceutical Technical Development in Switzerland and responsible for the Quality and GMP-compliance oversight...

  • Director, Commercial Affiliate QA Gmp Gdp and

    Vor 7 Tagen

    Basel, Basel-Stadt, Schweiz Idorsia Pharmaceuticals Ltd. Vollzeit

    About Idorsia Pharmaceuticals LtdIdorsia Ltd is reaching out for more - We have more ideas, we see more opportunities and we want to help more patients.In order to achieve this, we want to develop Idorsia into one of Europe's leading biopharmaceutical companies, with a strong scientific core.Headquartered in Switzerland - a European biotech hub - Idorsia is...

  • Technical QA Manager

    Vor 7 Tagen

    Basel, Basel-Stadt, Schweiz ITech Consult Vollzeit

    Technical QA ManagerTechnical QA Manager (M/F/d) - GMP / Pharma / Qualification / Validation / CSVProjekt:For our client, a big pharmaceutical company in Basel we are looking for Technical QA Manager (M/F/d).Background:Tasks & Responsibilities: Running, maintaining and continuously improving Qualification/Validation activities including Computerized System...

  • Technical QA Manager

    Vor 7 Tagen

    Basel, Basel-Stadt, Schweiz Coopers Group AG Vollzeit

    Technical QA ManagerYou will support the end to end cGMP activities, in maintaining the Right to Operate at the Swiss Technical R&D sites and in ensuring quality and compliance of IMP products according to Health Authority requirements and Company Standards for IMP products.You will be reponsible for running, maintaining and continuously improving...

  • Gruppenleiter QA Project Management

    Vor 7 Tagen

    Basel, Basel-Stadt, Schweiz Girardet Consulting AG Vollzeit

    Für unseren Pharma Kunden in Basler Raum suchen wir einen erfahrenen Gruppenleiter QA Project Management (m/w) für eine Festanstellung ab sofort oder nach Vereinbarung.**Ihre Aufgaben**:- Organisation, Führung und Entwicklung der eigenen Organisationseinheit- Sicherstellung der Unterstützung von Projektteams für Entwicklungsprodukte durch kompetente...

  • QA Manager

    vor 4 Wochen

    Basel, Basel-Stadt, Schweiz Randstad Vollzeit

    For our client, an international pharma company in Basel, we are looking for a QA Manager to support and oversee the end to end cGMP activities in implementation of Annex 1 requirements at the Clinical Supply Centre Basel. They take care that the Right to Operate can be maintained by ensuring that quality and compliance requirements according to Health...

  • QA Manager

    Vor 7 Tagen

    Basel, Basel-Stadt, Schweiz Randstad Vollzeit

    For our client, an international pharma company in Basel, we are looking for a QA Manager to support and oversee the end to end cGMP activities in implementation of Annex 1 requirements at the Clinical Supply Centre Basel. They take care that the Right to Operate can be maintained by ensuring that quality and compliance requirements according to Health...