- Super User of Laboratory computerized systems.
- Performs Audit trail review.
- Manages Master data for Laboratory software (e.g. Empower, Dissolution Workstation, Tiamo, etc.).
- Assures adherence to data integrity principles.
- Uses technical expertise to investigate and resolve technical issues in the laboratory
- Takes responsibility in selection, purchase and commissioning of new equipment
- Owns the change control, deviation and CAPA, leads or supports risk assessments
- Evaluates impact of compendial changes on applicable QC procedures and opens change controls as required
- Writes and reviews all types of GMP documents (e.g. SOP, TWI, URS, PQ, test method, validation protocols and reports, investigation reports etc).
- Supports internal and external audits
- QC representative in transversal project
- Maintains the GMP status of the laboratory
- In charge of the support of QC team members ("centre of competencies")
- · Supports maintenance/calibration of equipment and keeps relationship with suppliers
- · Can be assigned special duties and tasks
- Federal Certificate of Capacity as Laboratory Technician or similar education
- Minimum 5 years of work experience in a GMP environment
- Excellent knowledge in HPLC and GC techniques and CDS.
- Excellent knowledge of dissolution, UV/VIS and IR techniques.
- Knowledge of analytical method transfer and analytical method validation.
- Experience of doing analytical testing according to Ph. Eur. and USP prescriptions.
- Experience in laboratory equipment qualification.
- Very good communication skills.
- Very good writing skills.
- Excellent team spirit.
- Very good knowledge in English and French.
- Very good knowledge of most common office software.
- Good knowledge and/or ability to familiarize themselves quickly with new software and computerized systems (specific instrument software, LIMS).
- Capability for know-how transfer to and training of other QC team members.
Specialist Senior Analyst - Val-de-Travers, Schweiz - WuXi AppTec
Beschreibung
Overview
Job Summary:
This position is responsible to perform all Super User activities for the laboratory computerized systems. This includes at least Audit Trail Reviews and Master Data Management, optimization and/or new method setup, in adherence with data integrity principles as well as end user training, on-the-job training and equipment troubleshooting.
Additional responsibilities are selection, acquisition, and qualification of new analytical equipment by handling, writing and executing Change Control, User Requirement Specification and Performance Qualification protocol. Owns deviations, leads or supports laboratory investigations associated with equipment issues.
As a QC Team Member, the person filling this position supports all activities to continuously maintain the GMP status of the QC Laboratory.
As a Senior QC Team Member this position acts as a centre of competence reflecting experience, transferring knowledge and supporting other QC team members in all aspects of their daily work.
Responsibilities
Essential Job Functions:
Qualifications
Experience / Education
Knowledge / Skills / Abilities:
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability
This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.