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QA Deviation Management Specialist

Thermo Fisher Scientific -
Allschwil, BL

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Details zur Stelle

100% | Pensum: 90-100%
vor 13 Tagen

Qualifikationen

Englisch
Qualitätssicherung
Qualitätskontrolle
Organisationstalent
Ursachenanalyse
Kommunikationsfähigkeit
Deutsch

Vollständige Stellenbeschreibung

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

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.

You'll be based at our Allschwil site, which is the largest Thermo Fisher location in Switzerland and a key player in our Clinical Trials Division. We support every aspect of clinical trial supply, from clinical manufacturing (over-encapsulation, API microdosing) to primary and secondary packaging, labeling, distribution, returns, and destruction. As a central part of our Pharma Services business, Allschwil is where innovation meets excellence. Join a team that supports your professional growth, values collaboration, innovation, and excellence, and contributes to critical clinical trials that advance healthcare and improve lives.

DESCRIPTION:

As a QA Deviation Management Specialist within the Clinical Trials Division, you will play a key role in ensuring quality and compliance across our clinical trial operations. Reporting to the QA Manager, you will be responsible for reviewing and approving deviations, complaint investigations, corrective and preventive actions (CAPAs), and effectiveness checks.

Your expertise will contribute to maintaining the highest quality standards and driving continuous improvement within our operations.

KEY RESPONSIBILITIES:

Review and approvals of deviations, complaint investigations, CAPAs, and effectiveness checks
Mentor investigators to improvement the quality of investigations and CAPAs
Coordinate investigation approvals within required timelines, including support for batch release activities
Support the improvement of Quality Key Performance Indicators (KPI) through data analysis
Participate in Practical Process Improvement (PPI) initiatives and other quality and efficiency projects
Provide support to the broader Quality organization as needed
Support internal audits, client audits, and regulatory inspections

REQUIREMENTS:

Degree or relevant experience in the pharmaceutical industry, Quality Control/Quality Assurance, medication handling, life scientific field or a related scientific field is a must
Preferred Fields of Study: Biology, Chemistry, Engineering, Life Sciences, or equivalent

Knowledge of cGMP regulations and/or international regulatory requirements is preferred
Minimum 2 years of experience in deviation investigations, CAPA, change control, and root cause analysis is a must
Minimum 2 years of experience with quality management systems and documentation (e.g., TrackWise or equivalent) is a must
B2 or higher level in German and English are a must
Experience delivering training sessions is a plus
Excellent communication and organizational skills
High level of accuracy, accountability, and efficiency
Ability to work independently and collaboratively within cross-functional teams
Ability to manage priorities and meet timelines

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Erweiterte Suche

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QA Deviation Management Specialist

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Ich möchte aktuelle Job-E-Mails für Stellen als mentor in basel, bs erhalten

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