Supervise the entrusted products through the entire life cycle with regard to pharmaceutical quality
Taking actions needed to assure the products quality and compliance
Initiation, coordination, supervision and functional assessment of activities carried out by the relevant expert team
Act as an internal and external contact person for all issues concerning the pharmaceutical quality of third-party manufactured products
Coordination and controlling of all GMP relevant documents
Support the execution of the QA Due Diligence of New and Existing Contract Manufacturer
Review and Authorize Master Documents to assure regulatory compliance on the supplier’s level
Support the negotiation, preparation and approval of new Quality Technical Agreements (QTA's)
Perform/support periodic reviews of the QTA’s and amend previously existing Quality Agreements
Support preparation and execution of regular audits/technical visits

Bachelor’s degree in Pharmaceutical/Natural/Engineering science or related field
3+ years’ experience in quality control / analysis, production and / or quality assurance
Must have working knowledge of cGMPs and applicable international regulations/guidelines
Strong computer skills including MS Office , TrackWise and SAP
Good communication skills and resilience
Good command of the written and spoken English language

comprehensive medical insurance
OPD coverage
annual health checkups
term life and accident insurance
confidential emotional wellbeing support through our Optum Employee Assistance Program
healthy meals at work
holistic wellbeing initiatives
volunteering programs

Quality Operations Manager – ExM 1

Key skills