We are recruiting on a temporary contract, an experienced QA Specialist for a pharmaceutical manufacturing site. The position will involve shifts 2x8.
Responsibilities - Supports the design of Master Batch Records for bulk or packaged commercial drug products. - Is responsible for the review of executed batch records and associated. - QA samples (API, raw materials, bulk, semi-finished and finished products). - Ensure compilation and archiving of the documentation for compliance to GMP as appropriate. - Handles deviations, CAPA and change control related to packaging and warehouse or bulk and QC issues as assigned and to ensure the execution / follow up of escalation processes up to both international and the global level. - Handles in cooperation with partners GMP activities. - Writes new, revises and makes recommendations for SOP and quality documents for quality department and supported departments of manufacturing site. - Handles qualification and validation documentation for QA review of relevant documents / reports (DQ, IQ, OQ, PQ, Cleaning Validation, Process Validation) and supports execution. - Support during Authorities inspections, when requested. - Represents QA within department and cross functional project teams according to assignments. - Participate to recommendations for continuous improvements in Quality systems as required. - Contributes of regular reporting of quality processes metrics. - Ensures that all regulations concerning product security and all established working methods are respected within the area of responsibility.
Profile - At least 1-2 years of experience in Quality Control and/or Quality Assurance in a pharmaceutical company or other related industry. - BS in science or relevant discipline. - Good understanding of cGMPs and Swiss, EU, and FDA regulatory requirements. - Good understanding of Solid Oral Dosage from packaging and warehousing, or bulk and QC processes. - Excellent interpersonal, collaborative and organizational skills. - Works independently, yet effectively in a team environment. - Strong written & oral communication skills in both French and English. - Very good investigating and QA problem solving skills, has a keen eye for Quality, makes proposals and facilitate decision when escalation is needed. - Ability to focus attention to details and to handle multiple tasks while working against pressures of deadlines. - Collaborative, organisational. - Sense of responsibility, reliability, team spirit, initiative and service. - Knowledge of most common office software.
Contact Spring Professional Life Science : +41 58 233 40 20
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