Provide technical laboratory support for product development and customer requirement activities.
Responsibilities
Provide technical laboratory support for product development and customer requirement activities.
Develop a understanding of product and laboratory working methods to ensure accurate execution of assigned work.
Perform sample preparation and testing activities in strict accordance with established Standard Operating Procedures (SOPs), safety guidelines, and quality standards.
Maintain 5S standards, including cleaning spray booths, work areas, and equipment.
Collaborate with laboratory colleagues, teams, and supported departments to ensure project success and resolution of issues.
Quality Control Specialist II responsible for ensuring quality of analytical processes, data, and products, and compliance with regulatory requirements.
Compensation
Salary Range:
€27,510.00 - €51,090.00
Responsibilities
Research analytical deviations and complaints and define appropriate corrective and preventive actions.
Lead and develop the site Quality organization, including QA, QC and Quality Systems, and ensure regulatory compliance and quality excellence at the Janssen Biologics Leiden site.
Compensation
The anticipated base pay range for this position is: €129,800.00 - €224,480.00
Responsibilities
Lead and develop the site Quality organization
Set the Quality strategy and ensure quality, compliance and business objectives are delivered
Provide strategic direction and leadership on quality systems, product release, compliance and inspection readiness
Serve as the senior Quality authority for the site
Build and maintain strong relationships with regulatory authorities
Requirements
Advanced degree in a scientific or engineering discipline
Обеспечение соответствия производственных процессов требованиям лицензии, регистрационного досье и нормативных требований, участие в контроле качества, расследованиях отклонений и улучшении системы качества.
Compensation
Конкурентоспособный компенсационный пакет (зарплата и годовой бонус).
Responsibilities
Проверка производственных досье на соответствие лицензии и регистрационному досье
Участие в обеспечении, что каждая серия ЛС произведена и протестирована в соответствии с требованиями регистрационного досье
Участие в процессах касающихся отзыва продукции с рынка
Обеспечение того, что валидационные и квалификационные активности проводятся в соответствии с нормативными требованиями
Активное участие в решении проблем качества, разработка действий для предотвращения повторений отклонений
Requirements
Высшее образование (химическое, фармацевтическое, технология ЛС)
Assists chemists and chemical engineers conducting chemical and physical laboratory tests using instrumental techniques in making qualitative and quantitative analyses of solids, liquids and gaseous materials related to product development or quality control of production processes or products
Responsibilities
Determines the physical and chemical properties of compounds and materials using quantitative and qualitative chemical analysis
Performs a variety of chemical tests using instrumental methods and standard test equipment
Prepares materials for laboratory examination and conducts quality, safety, and compliance assessments
Follows established SOPs
Sets up and maintains lab equipment
Requirements
Vocational / Technical School or internal training program
Biotech Technician Associate (BTA) on the Cell Banking/Cell expansion team at our site in Dunboyne, Co. Meath.
Responsibilities
Execute automated recipes using paperless technology for drug substance production, including inoculation, cell culturing, filtration, and purification.
Set up single-use equipment between runs and carry out production processes according to GMP and EHS principles.
Optimize and improve processing activities using standard work and lean processing techniques.
Support operations team to consistently deliver on KPIs such as EHS metrics, Production Plan, OEE, compliance, and team training.
Complete Enablon Good Catches to support our safety culture.
Requirements
Level 5 Post Leaving Certificate Diploma in Science/Engineering/Computing/Culinary or equivalent
Total Base Pay Range: 47,100.00 - 67,300.00 - 87,500.00 EUR
Naast het basissalaris kun je, afhankelijk van vooraf bepaalde prestatiecriteria, in aanmerking komen voor een prestatiegerichte bonus.
Responsibilities
Afhandeling van OOx/deviaties, definiëren van CAPA’s en opvolgen van KPI-trends
Ervoor zorgen dat alle activiteiten voldoen aan cGxP, inclusief data-integriteitscontrole en goedkeuring van analytische data/tests (analytische vrijgave) en stabiliteit
Stabiliteitstesten binnen projecten: opstellen van protocollen, evaluaties en rapporten
Rapportage, waaronder het opstellen van stabiliteitsplannen, trendanalyses en evaluaties
Uitvoeren van stabiliteitsstudies, protocollen en vergelijkende rapporten voor leverancierskwalificatie
Requirements
Bachelor's degree in Pharmaceutical Laboratory Technology, Microbiology, Biotechnology, Chemistry or another relevant scientific discipline
Chemical Technician IGeneral Dynamics Ordnance and Tactical Systems · Crawfordville, US