Manufacturing Expert
Vor 4 Tagen
**About Us**
Consultys Group is a 100% specialist LifeScience consulting firm. With more than 550 experts working in France, Belgium, Germany and Switzerland on major engineering, R&D and compliance projects for the world's leading pharmaceutical, medical device and biotech companies.
Consultys links operational compliance, quality, processes, R&D, regulatory, own solutions and technology in ways that master complex business challenges to help its LifeScience clients exploit their existing strengths and develop new capabilities by combining its experience and innovative thinking across in the regulated environment.
**Role & Responsibilities**
- Contribute to the creation, maintenance, review and update of manufacturing processes, documents, and records to ensure completeness, accuracy, consistency and clarity as well as compliance to cGMP and QSR requirements
- Support the maintenance and continuous improvement of GMP/QSR quality systems
- Support regulatory filings and inspections of company, as related to reagent manufacturing practices
- Trains associates on operational procedures, as needed
- Ensuring that Quality Events such as incidents and deviations are properly documented, and for supporting/owning the immediate remediation and preventative actions
- Ensuring change requests are properly initiated, completed, and approved prior to the use of the assay, system, instrument, software, etc. being changed
- Maintaining up-to-date training records and ensuring training is complete prior to performing specific job functions
- Following approved and effective procedures to perform specific job functions, and ensuring procedures accurately reflect activities being performed
**Requirements**:
- University Degree in Sciences, Engineering or another relevant disciplines
- At least 3 years of experience within a GMP-regulated environment
- Strong knowledge of Pharmaceutical production processes, equipment and documentation
- Experience in Qualification, Validation, Calibration and Maintenance is a plus
- Analytical and structured working style; strong attention to detail
- Ability to effectively work as part of a multidisciplinary, international team
- Fluency in English is required, German, French or Italian would be a plus
- Hands-on personality, with flexibility and dedication to maximize our client's value
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