Manager Manufacturing Operations USP

Manufacturing/production/operations (Liquid, Aseptic/sterile, Fill & Finish, Solid In Production & Packaging):

• Organization, Construction, Sterile Production, Operations, Packaging, Scm/score, Sfm, Kpi, Cad, Cqv, Msat, Trainings, Audits, Ehs, Etc.
• F&f (A-e): Vials, Syringes/injections, Ampules, Combinations, Etc.
• Bulks (Among Others): Vials, Granulates, Tablets, Powder, Etc.
• Products (Commercial/clinical, Launch, Scale-up, Spin-off Dosage Forms): Biologics/bioconjugates, Cho/expicho, (M)rna/recombinants, Antivirals, Vaccines, Plasmids, Oncology, Penicillin, Api, Imp, Ds, Sm/lm, Atmp, Btm, And/ind, Otc, Generics, Mdr/ivdr, Etc.
• Fine Chemicals, Cosmetics, Plastics, Hc, Detergents, Adhesives, Etc.

Technique (Biotech, F&f/liquid, Solid):

• Liquid: Aseptic F&f, Rabs/isolator/lyo, Vi, Usp 5 Kl Bio Sut, Harvest, Centrifugation, Incubation, Skids, Cots, Hvac, Cqv, Vtop/ctop, Dq-pq/fat/sat, Ppq, Media Fill, Aql, Pv, Smoke Studies, Mes, Msat, Etc.
• Solid: Granulator, Coater, Extractor, Capsule/compression, Etc.

Quality (Corporate, Qa/qc, Fvp/qp, Qmb, Rp 52a Amg, Compliance Officer):

• Construction, Organization, Q Oversight, Qms Systems, Excellence, Cgmp/gmp/gxp Compliance, Inspections, Audits, Cqv, Etc.
• Rm, Dev/capa/cc Management, Brr, Releases, Trainings, Etc.
• Qc/analytics, Methods, Lean Lab, Mibi, Aql, Transfer Projects, Etc.

Ehs & Reach (Site Ehs, Ehs-ms/asm, Ims-systems, Regulatory Compliance, Energy):

• Safety Organization, Risk Management, Ehs Compliance/oversight, Excellence/sustainability, Process Safety, Representation, Etc.
• Inspections, Ehs Audits, Certification, Safety Checks, Trainings, Etc.

Regulatory Basics (Among Others):

• Fda, Ema, Swissmedic, Anvisa, Cfda, Kfda, Tpd, Sfkn, Cmdcas, Regional/rp/inspectorates And Authorities
• Cgmp/210/211/820/etc., Ich (Q7, Q8, Q9, Q10, Etc.), Gmp, Annex 1, 2, 15, Etc., Aide-mémoires, Pic/s, Ispe, Iso (14644, 14971, 15378, Etc.)
• Iso 9001/efqm, 14001, 45001, Scc, 18001, 13485, 14971, Etc.
• 52a Bimschg, 16. Bimschv, Betrsiv, Lmg/lmgb, Reach, Etc.

It (Among Others):

• Mes/pas-x/ai 4.0/siemens/rockwell, Erp, Kneat, Ebr, Comos, Etc.
• E-dms, Mastercontrol, Documentum, Trackwise, Lims, Etc.
• Ms Office/project, Sap, Office 365, Ennov, Biomedion, Etc.

Soft Skills (Self-assessment):

• My Skills And Leadership Passion For Sustainable Solutions, Potential Development And Excellence, My Strategic, Holistic And Pragmatic Approach
• My Clarity, Creativity, Transparency And Structure In Teamwork, In My Results And In My Communication
• My Drive To Be A Convincing Ambassador For Success.