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Senior Quality Representative (W/M)

Empresa que publica: NOVEX PHARMA LIMITED

Fecha de Publicación: 2017-Aug-14

Ciudad: Berkshire

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Req ID: R0011264

Novex Pharma Limited is the leading global pharmaceuticals company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmic, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.

Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.

As team member of Global Quality Control technical support – technical oversight you would be responsible for:

Support and lead oversight of analytical method lifecycle during clinical and commercial stages from initial delivery through routine use, replacement and obsolescence
Design method validation strategy together with method experts
Review and approve method validation protocols
Support and oversee method transfer strategy and comparability testing
Approve method transfer plans and protocols
ensure analytical method validations are compliant to applicable internal and external guidelines and procedures
Review and approve investigations of method related laboratory exceptions. Define appropriate corrective actions together with investigation team.
act as SME and technical advisor in the field of method validation and calibration of reference standards
Act as a link between Global QC departments (method introduction, analytical lifecycle management)
Oversee centralized ownership of analytical methods through centralized control and distribution of harmonized procedures
Serve as technical SME for responsible programs during agency inspections


Qualifications

Leadership capabilities
Several years of relevant industry experience
Works autonomously
Requires knowledge and proficiency in the design, execution, and validation of analytical techniques used in the laboratory such as HPLC, SDS-PAGE, Capillary Electrophoresis, Potency and Bioassays
Ability to troubleshoot method performance and propose corrections is essential
Background in analytics or natural sciences (university degree or similar)
Quality Control and method validation experience
Fluent in English and German
Excellent communication skills in a cross-cultural and cross-department environment
Excellent communication, interpersonal and organizational skills
Ability to work well both independently and in a team environment.
Ability to prioritize work and multitask
Project management experience would be a plus
Self-driven, highly motivated, cooperative and proactive
Organizational and problem solving skills
six sigma experience would be a plus
Project management experience would be a plus
Knowledge concerning cGMP (mainly QC related)
Willing to travel
Titulo de Empleo Senior Quality Representative (W/M)
Detalle de Empleo
Enviado por NOVEX PHARMA LIMITED
Tiempo del Contrato Permanent
Fecha de Inicio 31/08/2017
Salario 45000
Telfono 447024097775
Email careersnovexpharm.com
Ciudad Berkshire
Plazo 2017-Sep-01
Categora
Pas Lugar -> España
Tipo Tipo de Empleo -> Tiempo Completo y Parcial
Categora Categorias -> Medicina y Salud