Thomas Abegglen

Deputy of qualified Person, Batch release, supplier qualification (CMOs, contract labs, distributors, API suppliers, excipient suppliers, primary and secondary packaging material suppliers), Change control, Deviation and complaint Management. Responsible for Trackwise Change Control upgrade project as project lead.

Responsible for equipment qualification. Review, compilation and approval of qualification documentation such as DQ; FAT, SAT, IQ, OQ, PQ test plans and reports as well as change requests and deviation reports. Representation of equipment qualification during customer audits and ispections by the authorities. Compilation and Review of SOPs and MQPs.

Responsible for compilation of PQR and handling of respective customer requests. Coordination and execution of internal audits. Review and approval of manufacturing procedures. Compilation/updating and training of SOPs, compilation of balance sheet narcotics. Handling of complaints, Batch record review and deviation handling. Coordination of audits and inspections of authorities as well as back and front office. Representation of PQR during customer audits and inspections by the authorities.

Responsible for process validation and cleaning validation. Updating of validation master plan. Compilation of SOPs. Approval of manufacturing procedures. Representation of process validation and cleaning validation during customer audits and inspections by the authorities.