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 include participation in 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, and finished product samples in support of product introduction activities. Executes methods such as HPLC, GC, UVNIS, IR, dissolution, pH, conductivity, TOC, titration, weighing, etc.
Performs review of analytical data.
Executes 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 for the selection, purchase, and commissioning of new equipment.
Acts as QC representative in transversal projects.
In charge of supporting QC team members (
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