Simon Hockenhull Email & Phone Number

Ejby

Brenntag Biosector A/S, Elsenbakken 23, Dk-3600 Frederikssund

Project lead on risk assessment analyses and change requests in productionDuring bi-monthly audit: Factory and process presentation, factory tour guide, batch documentation and deviation presentation cGMP level maintenance and improving GMP to next level Finding of root cause and prevention of recurrence of deviationsEnsuring in-depth knowledge of chemical processes in productionEnsuring process validation and qualification of equipmentChange… Show more Project lead on risk assessment analyses and change requests in productionDuring bi-monthly audit: Factory and process presentation, factory tour guide, batch documentation and deviation presentation cGMP level maintenance and improving GMP to next level Finding of root cause and prevention of recurrence of deviationsEnsuring in-depth knowledge of chemical processes in productionEnsuring process validation and qualification of equipmentChange request and protocol preparationReview and follow up on batch records; writing and investigation of deviations before submitting to QATraining of peers and operatorsHotline support for operators Show less

Brenntag Biosector A/S, Elsenbakken 23 Dk-3600 Frederikssund

Project lead on risk assessment analyses and change requests in productionAudit responsiblecGMP level maintenance and improving GMP to next level Finding of root cause and prevention of recurrence of deviationsEnsuring in-depth knowledge of chemical processes in productionEnsuring process validation and qualification of equipmentChange request and protocol preparationReview and follow up on batch records; writing and investigation of… Show more Project lead on risk assessment analyses and change requests in productionAudit responsiblecGMP level maintenance and improving GMP to next level Finding of root cause and prevention of recurrence of deviationsEnsuring in-depth knowledge of chemical processes in productionEnsuring process validation and qualification of equipmentChange request and protocol preparationReview and follow up on batch records; writing and investigation of deviations before submitting to QATraining of peers and operators Show less

Responsible for antibiotics production in fermentation.Management of 17 operators. Training and administration.Ensure compliance and GMP.Member of management group.

Areas of competence and responsibility:Responsible for antibiotics production in site.Management of shift teams.Prioritising staff resources with a view to ensuring compliance with production goals and delivery schemes.Responsible for sampling and delivery of samples.Responsible for compliance with GMP and legislative rules.Member of management group

Areas of competence and responsibility:Optimising and documentation of production processes and production output. Training of staff in SOPs, guidelines and GMP regulations. Control and approval of batch documentation. Batch release for QA.Participation in inspections and audits.• cLEAN 1*• Kaizen responsible.• Various databases• Responsible for classified environments.• SOP updating

Areas of competence and responsibility: Production techniques:Fermentation Purification (UF) Filtration Membrane treatment (UF and HF) Ion exchange Spray drying Validation:Run-in of new production plantDocumentation:Control of batch documentationLabeling control Laboratory:Hydrolysis after GPC columnsTitration Analysis and control of final product