QA Deviation Management Specialist

Work Schedule

Environmental Conditions

Job Description

As part of the Thermo Fisher Scientific team youll 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 worlds toughest challenges like protecting the environment making sure our food is safe or helping find cures for cancer.

Youll 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