Anders Wind Email & Phone Number

Copenhagen, Capital Region, Denmark

Ballerup, Capital Region, Denmark

Continued work on the LEO FAR project.

Ballerup, Capital Region, Denmark

Due to end of life cycle for the sterile API facility, I was due to my previous experience in the department asked to take the role as production chemist and primary GMP responsible until close-down of the facility, alongside project work. Here, I also participated in the following activities;- Production and release detail planning- Delivering data for tech transfer of the process to new MA holder- Participation in decommissioning preparation activities

Ballerup, Capital Region, Denmark

Operational Readiness specialist for project phase of building a new facility containing fermentation, recovery and final purification of Fucidin® API, including black utility, clean utility etc. Ensuring compliance with cGMP and regulatory requirements while remaining focused on integration with LoB.Main responsibilities- OR responsible for final purification- OR responsible for Clean Utilities with focus on PQ- Responsible for classified rooms, including RA and strategy for environmental monitoring- Creating and execution of GMP documents including qualification / validation documents and SOPs, Work Instructions etc.- Project management, including project change managementFurthermore- Participation in development and review of design documentation (URS, FS, FSS, etc)- Involved in RA work within process, utilities, safety- Integration of new project into existing frameworks and systems (SAP, LIMS etc)

Ballerup

With the new role I became an even more integral part of the daily planning and decision making. Several responsibilities were added to my job description hereunder:- Production planning- Planning of release - Authority of process owner for equipment

Ballerup

As a production chemist in the Fucidin® sterile department at LEO Pharma I have worked with coordination and support of production of a sterile API. Amongst my primary responsibilities were:- Ensuring compliance with cGMP and regulatory requirements including Annex 1- Deviation handling including CAPAs, Change Control cases, and audit NCs- Review of batch documentation and other release-related GMP documents- Planning and prioritization of production activities- Creating, update and review of GMP documents including qualification / validation documents, SOPs, WIs and batch master documentation- LEAN activities such as Systematic Problem Solving and Continuous Improvement (A3)- Project management for smaller improvement projects

Odense Området, Danmark

Master’S Degree, Chemical Engineering

The academic profile is Chemical Process Engineering which includes: - design new plants for use in the chemical, biochemical.

Bachelor’S Degree, Chemical Engineering

Bachelor's degree in engineering within focus on chemistry and biotechnology. The education provides not only theoretical knowledge.

Stx, Kemi, Matematik, Fysik

Activities and Societies: Scientific line of study. Chemistry A, Mathematics A, Physics B.