Posted Sep 14, 2017 4 views
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 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 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
Skills
Job Details
Novex Pharma Limited
Novex Pharma Limited is an active company incorporated on 30 August 1984 with the registered office located in Berkshire. Novex Pharma Limited has been running for 32 Years 11 Months. Offering true quality takes a lot more than technology. At our Irvine facility, we have combined the most appropriate resources with the best human resources. Each member of staff shares the Novex commitment to excellence and our systems are tested to exacting standards, offering full traceability on production batches and raw materials.
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