Analyst QC Analytical Technical Support

Vor 4 Tagen

Basel, Schweiz Gi Group SA Vollzeit

For our client company, we are looking for a

 

Analyst QC Analytical Technical Support

Specialist Analytical Tech Support x2 (2 open position)

Duration : 01.07.2024 until 31.05.2026

Temporary contract

Site : QC Boudry - Celgene International

Langues : French and English - Professional proficiency

Other : Good communication Project cooordination

 

Position Summary

In this role you will perform super user activities for the laboratory computerized systems, including Master Data Management, and associated GMP document updates. This position will act as a Super User providing support and training to End-Users of the QC laboratories as well as supporting investigations and resolution of issues. The Specialist will report to the Sr. Manager QC Analytical Tech Support.

 

Key Responsibilities

Super user of laboratory computerized systems:

Performs master data management activities and new methods set up in computerized systems (e.g Empower, Dissolution Workstation, Other systems as assigned).

Executes verification protocol for custom calculations.

Performs audit trail reviews and assures adherence to data integrity principles.

Assists QC End Users with software issues.

Provide end user training and on-the-job training for new employees where required.

Updates and reviews associated GMP documents and procedures.

Support change controls for QC software.

Supports risk assessments.

 

Equipment lifecycle activities.

Performs feasibility experimental work as needed.

Supports decommissioning of analytical equipment.

Supports End-User with equipment troubleshooting.

 

Promotes safe practices and behaviors.

Reports immediately incidents to Environmental Health and Safety department, participate in investigations and identify measures to prevent similar accidents in the future.

Demonstrate Bristol Myers Squibb values.

 

Performs other tasks as assigned.

 

Qualifications & Experience

Education and Experience

 

Federal Certificate of Capacity as Laboratory Technician or BS degree in Life Science, Chemistry, or relevant scientific discipline or equivalent combination of education, training, and experience.

Minimum 2 years relevant work experience required, preferable in a regulated pharmaceutical environment.

Scientific and practical knowledge of analytical techniques (e.g., chromatography techniques (High-performance liquid chromatography, Ultra-performance liquid chromatography, Gas chromatography), Dissolution, UV/VIS, and IR techniques).

Previous experience of laboratory equipment qualification is preferable.

 

Required Competencies: Knowledge, Skills, and Abilities

Good scientific knowledge of chromatography techniques (HPLC, UPLC, GC), dissolution, Karl Fischer, and spectroscopic techniques.

Exceptional knowledge of LIMS and Empower applications.

Advanced knowledge and interpretation of cGMP, ISO, FDA, MHRA and Pharmacopeia requirements, and good documentation practices.

Advanced knowledge of Data Integrity principles, familiar with audit trail review requirements.

General computer literacy including MS Office (Word, Excel, PowerPoint, Outlook)

Effective verbal communication skills, ability to interact with different levels of the organization and departments.

Effective technical writing skills, experience writing GMP documents (procedures, protocols, plans and reports).

Proven analytical, problem-solving, and continuous improvement skills.

Proven time management skills and a strong attention to detail.

Ability to work independently and compliantly.

Physical ability to perform tasks that may require prolonged standing, sitting, and other activities necessary to perform job duties.

 

Fluent in English or French and professional command of the second language (written and verbal).

 

For more information please contact zahra.safari@gigroup.ch.



Branche: Pharma-Industrie

Funktion: Qualitätsprüfung

Anstellungsart: Temporäre Arbeit

Karrierestufe: Angestellte/r



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