27.04.2020
POSIZIONE CHIUSA
For our important customer we are researching the following profile:
QC MANAGER
Responsibilities:
Designing, planning, implementing and supervisiong the QC Laboratory and perform the quality control analysis of therapeutic proteins by: managing and performing Microbial and Physico-Chemical testing of raw materials, in-process and in final products managing and performing cleanroom and utilities microbial monitoring; providing appropriate quality for product manufacture managing and performing Physico-Chemical analytical determinations of the utilities of the plant ensuring the laboratory is operated in a safe manner ensuring an effective quality management system is in place within the laboratory through appropriate root cause analysis for any deviations and through an appropriate investigation an impact assessment for any out of limits supporting and coaching of Laboratory Supervisors and Thechnicians, providing motivation to the team and take appropriate corrective action on individual/team performance where required - Ensuring SOPs and all the documentation are followed, in compliance with cGMP
- Ensure that testing is completed in line with EP/USP and registered specifications and is performed within defined timelines as per SOP, in compliance with the regulatory requirements
- Address and manage the validation protocols and reports of analytical methods and processes
- Ensure that environmental monitoring and utility monitoring is supported with environmental monitoring risk assessment
- Supporting contamination control strategies manufacturing operation
- Perform assessments of personnel activities versus the SOP to ensure compliance
- Take part to internal and external audits
- Work closely with the production management team on-site, providing assistance in investigationof OOS events and supporting batch assessement and CAPA
- Managing and supporting Microbiology and Physico-Chemical Laboratory Supervisors and Technicians
- Responsible for Quality System within the laboratory and ensuring timely completion of reports and investigations, written to a high standard
- Ensuring effective monitoring and control of cleanrooms, utilities and contamination control strategies are supporting therapeutic proteins manufacturing
Requirements - Degree in chemistry, Biology, Biochemistry, Biotechnology or similar educational background
- At least 7 years of experience within QC an GMP environment
- At least 5 years of experience in management roles
- Broad and experiential knowledge of Pharmaceutical Quality and GMP practices
- Strong background in Microbiology and Analytical chemistry operations
- Extensive knowledge of microbiology/analytical chemistry tasks and associated regulatory standards and guidance
- Ability to anticipate, understand and address the changing regulatory environment and guidelines of the industry
- Strong interpersonal and communication skills, verbal and written
- Fluent in English and Italian
If your experience fits with the listed requirements please send your application to: largader@lwphr.ch. Mr. Alberto Largader is the person in charge for the selection.
No reply will be given to the non-compliant applications.
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