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Specialist Senior Analyst

vor 4 Monaten


Couvet, Schweiz WuXi AppTec Vollzeit

Job Overview:

This role involves being the go-to person for managing all Super User activities related to the laboratory computerized systems. Responsibilities include conducting Audit Trail Reviews, overseeing Master Data Management, optimizing and setting up new methods while ensuring data integrity standards are met. Additionally, the role involves providing end user training, on-the-job training, and troubleshooting equipment issues.

Other duties include selecting, acquiring, and qualifying new analytical equipment by handling Change Control procedures, User Requirement Specifications, and Performance Qualification protocols. The individual will take ownership of deviations, as well as lead or assist in laboratory investigations related to equipment problems.

As a key member of the QC Team, the incumbent will contribute to maintaining the GMP status of the QC Laboratory.

As a Senior QC Team Member, this role serves as a pillar of expertise, sharing knowledge and offering support to fellow QC team members in their daily tasks.

This is a Long-Term Temporary Role.

Key Responsibilities:

  • Act as the Super User for Laboratory computerized systems.
  • Conduct Audit Trail reviews.
  • Manage Master data for Laboratory software tools such as Empower, Dissolution Workstation, and Tiamo.
  • Ensure strict adherence to data integrity principles.
  • Utilize technical proficiency to troubleshoot and resolve laboratory technical issues.
  • Take charge of selecting, purchasing, and commissioning new equipment.
  • Handle change control, deviations, and CAPA processes, and lead or support risk assessments.
  • Evaluate the impact of compendial changes on relevant QC procedures.
  • Prepare and review various GMP documents like SOPs, TWIs, validation protocols, and investigation reports.
  • Support internal and external audits.
  • Represent QC in cross-functional projects.
  • Maintain the GMP compliance of the laboratory.
  • Act as a mentor to QC team members.
  • Support equipment maintenance/calibration and liaise with suppliers.
  • Undertake special duties and assignments as needed.

Experience / Education Requirements:

  • Hold a Federal Certificate of Capacity as a Laboratory Technician or equivalent qualification.
  • Minimum of 5 years of experience in a GMP environment.

Skills and Qualifications:

  • Proficient in HPLC and GC techniques and CDS.
  • In-depth knowledge of dissolution, UV/VIS, and IR techniques.
  • Familiarity with analytical method transfer and validation.
  • Experience in conducting analytical testing following Ph. Eur. and USP guidelines.
  • Skilled in laboratory equipment qualification.
  • Strong communication and writing abilities.
  • Excellent team player.
  • Proficiency in English and French.
  • Good command of common office software.
  • Quick to learn new software and computerized systems like specific instrument software and LIMS.
  • Capable of transferring know-how and training other QC team members.

We are an Equal Opportunity Employer. Qualified applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status, and will not face discrimination based on disability.

Please note, this job description is not exhaustive and individuals in this role may be assigned additional job-related responsibilities as requested by Management.