Candidatura

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 Technician
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: [email protected] Mr. Alberto Largader is the person in charge for the selection.

No reply will be given to the non-compliant applications.

Ledermann
Via Vegezzi 4
6900 Lugano

Ledermann Wieting & Partners SA
+41 (0) 91 921.48.78
+41 (0) 91 921.45.69