QA Audit Manager

Vor 7 Tagen

Basel, Schweiz Thermo Fisher Scientific Vollzeit

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

Quality Assurance Audit Manager - Sr. Quality Assurance Specialist

About the role

This role provides a unique opportunity to be part of a growing pivotal initiative to reshape and build out the clinical supply chain for CTD in a way that allows us to leverage information for our clients and our internal partners to enhance our growth potential and customer service. The position holder is responsible for client-facing activities within the Quality Assurance department including participation in client audits. The position holder will also participate in various compliance-related activities within Fisher Clinical Services.

**Discover Impactful Work**:
Applies expert knowledge of GMP regulations to improve and integrate across value streams (manufacturing, packaging, distribution, labeling, and comparator)

Demonstrates pharmaceutical Quality expertise to recommend solutions to both internal and external clients to ensure compliance across the supply chain

Maintains, develops and builds strategic client relationships

Key Duties & Responsibilities

Managing and hosting client audits

Coordination of CAPAs in response to client audit findings

Follow-up of CAPAs in order to ensure prompt resolution and closure

Participation in Internal Audits as Auditor/Support Team, supporting the organization, execution, writing of audit report, opening and closure of audit records in the TrackWise event management system

Initiation and implementation of measures to prevent quality deviations and reduce risk

Data collection and analysis of Key Performance Indicators for site Quality goals

Handling of complaints / deviations to ensure appropriate CAPAs to avoid recurrence

Participation in Gembas, Kaizen, Practical Process Improvement projects

Participation in Risk Assessments

Participation in interdepartmental working groups and global project teams

Acting as local client QA Lead for various clients including participation in routine teleconferences, Quality review meetings, and maintenance of client-specific metrics

Education & Background

3+ years pharmaceutical GMP experience

Excellent written and oral communication

Excellent organizational skills

High level of accuracy and efficiency

Fluency in German and English preferred

GMP knowledge

Excellent interpersonal skills

Ability to manage projects through implementation

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

  • QA Audit Manager

    vor 1 Woche

    Basel, Schweiz Thermo Fisher Scientific Vollzeit

    The Quality Difference at Thermo Fisher Scientific: What makes our quality teams unique is a shared passion for getting it done right the first time and working for the right reasons with our customers always in mind. Our team of Quality professionals understand our customers rely on the accuracy, safety, and effectiveness of our products and services that...

  • Clinical QA Manager and Auditor

    Vor 5 Tagen

    Basel, Schweiz Evergreen Theragnostics Vollzeit

    Direct message the job poster from Evergreen TheragnosticsVice President Human Resources | Senior Human Resources ProfessionalClinical Quality Assurance (QA) Manager and AuditorEvergreen Theragnostics, Inc. is a radiopharmaceutical company headquartered in Springfield, NJ. We operate in a brand-new state-of-the-art facility, developing our own...

  • Technical QA Manager

    vor 1 Woche

    Basel, Schweiz Talentify Vollzeit

    Description Our client is seeking an experienced Technical QA Manager to join their IMP Quality Operations Unit in Basel. This team plays a critical role in ensuring GMP compliance and quality oversight for Investigational Medicinal Products (IMPs) manufactured and packed in Switzerland. The ideal candidate will bring extensive expertise in qualification and...

  • QA Manager

    vor 1 Tag

    Basel, Schweiz GITR Vollzeit

    **EINFÜHRUNG**: As a preferred supplier for Roche in Basel/ Kaiseraugst, we are looking for an individual as **QA Manager**: with a one year contract and possible extension. The start date is within asap or within 3 months. Home Office will be possible but min. 50% onsite is required. **AUFGABENBESCHREIBUNG**: - Running, maintaining and continuously...

  • QA Auditor Compliance Manager

    vor 1 Tag

    Basel, Schweiz CTC Resourcing Solutions Vollzeit

    **_The Life Science Career Network_** **QA Auditor Compliance Manager** Our client is a pioneer in Drug Discovery and Development and one of the frontrunners in Personalised Healthcare. As the world's largest R&D spender in the pharmaceutical and diagnostics domain, they work in a vast number of drug discovery & therapeutic areas and are highly recognized...

  • Sustainability Reporting Manager

    Vor 3 Tagen

    Basel, Schweiz Audit International Vollzeit

    Job type: Perm Town/City: Basel Country: Switzerland Salary/Rate: 0 Specialism: Internal Audit Seniority: Manager Job ref: JMK79 Post Date: 07.11.24 About the Role Responsibilities Manage non-financial annual reporting: Set reporting standards and requirements, lead cross-functional reporting team, ensure data integrity and...

  • QA Auditor – Compliance Manager

    Vor 6 Tagen

    Basel, Schweiz CTC Resourcing Solutions Vollzeit

    QA Auditor Compliance Manager – 6263 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 Auditor Compliance Manager for 1 year contract with high possibility of extension based in...

  • Technical QA Manager

    vor 24 Stunden

    Basel, Schweiz Flexsis Vollzeit

    As a preferred supplier for Roche in Basel, we are looking for an individual.Technical QA Manager (m/w/d)This is a full-time position (100%) with a 1-year duration and the possibility of extension. The ideal start date is as soon as possible and the latest 01.04.2025. Home Office: Onsite required, home office upon discussion.Responsibilities:QA supervision...

  • QA Manager

    vor 1 Tag

    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...

  • QA Auditor Compliance Manager

    Vor 3 Tagen

    Basel, Schweiz Halian Vollzeit

    Job ResponsibilitiesEnsure GMP compliance at third party service providers and within internal facilities.Lead or assist in establishing external QA Audit and internal self-inspection annual Plan.Conduct GMP/GDP audit and self-inspections and coordinate with internal personnel and suppliers to schedule, execute and follow up with audit observations.Promptly...

  • QA Expert

    vor 1 Tag

    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 1 Woche

    Basel, Schweiz Aequor Consulting GmbH Vollzeit

    For one of our renowned clients in the pharmaceutical and life sciences industry, we are looking for a dedicated and qualified QA Expert / Senior QA Specialist Instrument Qualification (m/f/d) in Basel. Our client is known for innovation, top-quality standards, and pioneering solutions. Join a team that pushes the boundaries of science and sets global...

  • QA Manager CMO Management

    Vor 3 Tagen

    Basel, Schweiz gloor&lang AG Vollzeit

    End to End Quality Stewardship - Basel --- | Our customer is an innovative international biopharmaceutical company with offices in Basel. Intense R&D activities gave rise to an exciting pipeline of new promising drugs, many of which successfully reached commercialization stage. With a strong portfolio of on-market products, and an extensive portfolio of...

  • QA Engineer

    vor 18 Stunden

    Basel, Schweiz ALTOGEN AG Vollzeit

    COMPANY:ALTOGEN SWITZERLAND is a Swiss engineering and consulting company specialized in life sciences with proven expertise in pharmaceuticals, biotechnology, and medical devices. Since December 2023, Altogen Switzerland has been part of the EFOR Group.With several years of experience, technical expertise, and project coordination, we support our partners...

  • QA Manager GMP/GDP

    Vor 6 Tagen

    Basel, Schweiz CTC Resourcing Solutions Vollzeit

    QA Manager (GMP/GDP) – 6166 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 Manager with GMP and/or GDP experience for 1 year contract with high possibility of extension based in...

  • Quality Assurance

    vor 1 Tag

    Basel, Schweiz ALTOGEN AG Vollzeit

    **Quality Assurance & Regulatory Affairs (QA/RA) Manager - Medical Devices** ALTOGEN is a Swiss engineering and consulting company specialized in life sciences with proven expertise in pharmaceuticals, biotechnology, medical devices. With several years of experience, technical expertise and project coordination, we support our partners throughout all areas...

  • QA Manager CMO Management

    Vor 3 Tagen

    Basel, Schweiz gloor&lang AG Vollzeit

    End to End Quality Stewardship - Basel Our customer is an innovative international biopharmaceutical company with offices in Basel. Intense R&D activities have given rise to an exciting pipeline of new promising drugs, many of which successfully reached the commercialization stage. With a strong portfolio of on-market products and an extensive portfolio of...

  • Manager QA and Regulatory Compliance Basel, Switzerland | Full-Time | Permanent

    Vor 3 Tagen

    Basel, Schweiz Vectura Group Vollzeit

    You may find making an application much easier from a desktop computer. So why not forward yourself a link to this vacancy to pick up and apply on a desktop or laptop later? Alternatively, you can send the link to someone you think would be suitable for the role.Who we areVectura Fertin Pharma’s ambition is to become a market-leading wellness and...

  • Quality Assurance Manager

    vor 1 Woche

    Basel, Schweiz Hengrui Europe Therapeutics AG Vollzeit

    **Job Title**: Quality Assurance Manager **Reports to**: Global Head of Quality Assurance & Training **Department**: Quality Assurance & Training **Location**: Basel, Switzerland OR New Jersey, USA **Direct reports**: No The Hengrui ex-China organization drives the development and commercialization of the Hengrui innovative medicines portfolio for the...

  • QA Expert

    vor 24 Stunden

    Basel, Schweiz Brine SA Vollzeit

    QA Expert / Senior QA Specialist Instrument Qualification (Ref.Nr. KR3243)We are looking for a person who can:BRINE SA has been placing top specialists at well-known customers for over 30 years. In doing so, we focus on performance, competence, experience, and partnerships.BRINE SA is looking for an experienced QA Expert / Senior QA Specialist Instrument...