Quality Assurance Director; Senior Manager QA Compliance; Laboratory Manager Quality Control; Head of Regulatory Affairs; professional and disciplinary management of employees; cGMP-Compliance; customer audits and Authority inspections; risk management; GMP-audits; qualification and validation; regulatory affairs; sterile manufacturing (on a contract basis; aseptic filling; terminal sterilization; lyophilization; visual inspection and secondary packaging); responsible for GMP - training; data integrity; cleaning validation; deviation- and CAPA - management; change control; self inspections, supplier–/service provider qualification; Product Quality Reviews; pest control; environmental monitoring; Quality Management reviews; validation master plan; annual reviews of GMP – relevant utility systems; development/transfer and validation of chemical-analytical test methods