We are looking for a quality assurance manager to join a diverse team and be responsible for Quality and aseptic oversight of equipment used for parenteral manufacturing.
Provide Quality and Compliance guidance to assigned departments
Perform Quality and aseptic oversight on the shop floor
Active contribution to new concepts and projects as well as suggestions for improvement in the above-mentioned areas
Proactive risk mitigation
Assessment and approval of Quality issues/ investigations (QIs) and CPAs related to facility, environment and equipment. Investigation quality lead for major non-conformances (deviations)
Review and approval of Protocol, Reports, SOPs/WIs, Change requests (COCs) and further documents
Review and approval of GMP critical SAP master data (e. g. bill of material, manufacturing instructions etc.)
Participation as Subject Matter Expert in Health Authority inspections and audits
Bachelor or Master Degree in a microbiological, technical or science field
Proven experience in a GMP regulated aseptic Pharma production environment or experience in a relevant quality role
Strong technical and process background in sterile fill and finish production
Advanced skills in English (oral and written) and min. conversational German
This role is offered 12 months contract basis and with flexibility between home and office work.
Michael Bailey International is acting as an Employment Business in relation to this vacancy.