Overview

　　Job Summary:

　　This position is responsible to support all day-to-day QC routine activities such as Audit Trail Review, troubleshooting, investigations, software super user role and responsible for new lab equipment and operating software implementation.

　　Additional responsibilities are the handling of deviations and change controls and management of laboratory master data.

　　This position is not involved in routine commercial analytical testing for release of raw and packaging materials, final product and stability samples as well as all IPC testing.

　　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:

　　Writes and reviews all types of GMP documents (e.g., SOP, TWI, URS, PQ, test method, validation protocols and reports, investigation reports etc).

　　Owns the change control, deviation and CAPA, leads or supports risk assessments linked to the equipment and software discrepancies

　　Evaluates impact of compendial changes on applicable QC procedures and opens change controls as required

　　Supports internal and external audits

　　QC representative in transversal project

　　Uses technical expertise to investigate and resolve technical issues in the laboratory

　　Maintains laboratory equipment and software in accordance with cGMPs, Part 11 and other regulatory requirements.

　　In charge of the support of QC team members (“centre of competencies”)

　　Takes responsibility in selection, purchase and commissioning of new equipment

　　Supports maintenance/calibration of equipment and keeps relationship with suppliers

　　Super User of Laboratory computerized systems

　　Manages Master data for Laboratory software (e.g. Empower, Tiamo, etc.)

　　Assures adherence to data integrity principles

　　Performs Audit trail review

　　Can be assigned special duties and tasks

　　Qualifications

　　Experience / Education

　　Federal Certificate of Capacity as Laboratory Technician or similar education

　　Minimum 5 years of work experience in a GMP environment

　　Knowledge / Skills / Abilities:

　　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

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　　We can recommend jobs specifically for you!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 disabilityAn 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 (https://careers-wuxiapptec.icims.com/connect?back=intro&findajob=1&in_iframe=1&hashed=-435740542)

　　Job Locations CH-NE-2108 Couvet

　　Job ID 2024-12520