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Associate Specialist QA

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Associate Specialist QA
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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Please apply directly online by clicking on "Apply Now".
About Us
Advance your career, find a job that you love or discover a new opportunity for professional growth - we believe in these goals and work every day to help you achieve them. Spring Professional is a subsidiary of The Adecco Group specialising in temporary and permanent placement of qualified professionals.
Find out what we can do for you. Apply for this job, or for one of over 500 other vacancies at SpringProfessional.ch
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