This role support/provide quality oversight in ensuring a smooth manufacturing operation, new product launches/transfer in a compliant/timely manner, drug substance batch review/release are in full gmp compliance to regulatory standards and ensures quality strategy/continuous improvement are executed in alignment to site objectives.

Key Responsibilities
Your responsibilities include, but are not limited to:

• Operational

o Oversight of all production and testing activities, ensures compliance with c Gx P, incl. data integrity and
o e Compliance
o Support exception investigations (complex/critical)
o Support change control activities relating to complex changes
o Support Op Ex improvement projects
o Execute batch release in compliance with registration according to local requirements as technical responsible person

• HSE

o Comply with all HSE guidelines
o Detect and report potential accident, risks and propose solutions
o Participate in HSE risk assessments
o Preparation and participation to internal HSE audits
o Responsible for participating in initial training and retraining