Senior Manager QA Operations

at  WuXi AppTec

Overview:
The Senior Analyst is part of the Quality Control (QC) department of STA Pharmaceuticals Switzerland. He/She is responsible for executing protocols for method validations, verifications and transfers for the QC Laboratory. The position will also perform all testing of both material and finished product in support of the larger product introduction activities e.g. testing of samples for stability registration studies, process validation or cleaning validation. Additional duties includes participation to investigations in case of deviations, cleaning validation, preliminary testing, and preparation or review of documentation
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 center of competence reflecting experience, transferring knowledge and supporting other QC team members in all aspects of their daily work.

Responsibilities:

• Performs analytical testing of raw material, in process, finished products samples in support of product introduction activities. Execute methods as HPLC, GC, UVNIS, IR, dissolution, pH, conductivity, TOC, titration, weighing etc..
• Performs review of analytical data.
• Execute protocols, methods, and procedures with adherence to cGMP documentation requirements.
• Writes or reviews all types of GMP documents (e.g. test method, SOP, WPR, validation protocols and reports, investigation reports etc.
• Handles deviations and OOS in the applicable software tool
• Handles change control in the applicable software tool
• Supports internal and external audits
• Takes responsibility in method transfer and method validation activities.
• Takes responsibility in selection, purchase and commissioning of new equipment.
• QC representative in transversal project.
• In charge of the support of QC team members ("center of competencies")
• Performs basic laboratory work (buffer preparation, waste disposal management, washing of lab dishes, cleaning of the labs etc.)
• Supports maintenance/calibration of equipment and keeps relationship with suppliers.
• Can support commercial or other activities in QC
• May be assigned special duties and tasks (e.g. responsibilities for EHS, LIMS, computerized systems…)

EHS: This position is responsible to ensure all EHS requirements in the laboratory.

• Respect EHS procedure and rules
• Report immediately all incidents and near-misses to the management and/or to the EHS representative people

Qualifications:

EXPERIENCE / EDUCATION

• Federal Certificate of Capacity as Laboratory Technician or similar education
• 4-5 years of work experience in a GMP environment
• Experience of doing analytical testing according to Ph. Eur. and USP prescriptions.

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.
• 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 and capability of handling more complex lab software (e.g. LIMS).
• Capability for know-how transfer to and training of other QC team members.

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

• Performs analytical testing of raw material, in process, finished products samples in support of product introduction activities. Execute methods as HPLC, GC, UVNIS, IR, dissolution, pH, conductivity, TOC, titration, weighing etc..
• Performs review of analytical data.
• Execute protocols, methods, and procedures with adherence to cGMP documentation requirements.
• Writes or reviews all types of GMP documents (e.g. test method, SOP, WPR, validation protocols and reports, investigation reports etc.
• Handles deviations and OOS in the applicable software tool
• Handles change control in the applicable software tool
• Supports internal and external audits
• Takes responsibility in method transfer and method validation activities.
• Takes responsibility in selection, purchase and commissioning of new equipment.
• QC representative in transversal project.
• In charge of the support of QC team members ("center of competencies")
• Performs basic laboratory work (buffer preparation, waste disposal management, washing of lab dishes, cleaning of the labs etc.)
• Supports maintenance/calibration of equipment and keeps relationship with suppliers.
• Can support commercial or other activities in QC
• May be assigned special duties and tasks (e.g. responsibilities for EHS, LIMS, computerized systems…