Naja Bach

Dedicated and adaptable professional with a proactive attitude and the ability to learn quickly. Strong work ethic and effective communication skills.

Eager to contribute to a dynamic team and support organizational goals.

Results-driven individual with a solid track record in delivering quality work.

Proficient professional bringing several years of experience working in compliance-related roles with both internal as external stakeholders.

• Office (Word and Excel)
• SAP (E1P, BW and GBT)
• Veeva Quality system
• LIMS
• Adobe (Professional DC and Illustrator)

True, NC, True

• Danish, Native Language, perfect in both writing and speaking
• English, Fluent in both writing and speaking
• Swedish, Basic knowledge to conduct a conversation

06/01/22, 06/01/25, Handling different projects such as: New material substitute for existing raw materials used for PPM, writing SOPs for job clarification, optimizing flow for packaging materials to the line, new design features for secondary packaging materials, Training new personnel and being the communication channel between departments both in the US as well as international sites., 06/01/22, 06/01/25, Creating a structure in Novo Nordisk to handle the bridge between vendors and the Novo Nordisk facility in Clayton, North Carolina. Training internal and external stakeholders in SPS tools and help navigate all the different specifications that adhere to the agreements., 01/01/24, 12/31/24, Updating QC testing methods for cartons, leaflets and labels. Writing new procedure for responsibility areas within the departments: Packaging line support engineers, business support, QC/QA and SME., 01/01/23, 12/31/24, Update carton design for Ozempic cartons to make sure the design would not fail on the packaging line. Saved the tender for Ozempic to Canada with this upgrade in specifications., 01/01/19, 12/31/20, Identify and implement solution for a smooth-running PS PAC warehouse in Alleroed after main building project is closed down., 01/01/16, 12/31/19, Build up a new quality support department within purchasing, which will handle Supplier complaints., 01/01/15, 12/31/16, HAIKU project to clinical test (Build 7, sent for test in November 2015)., 01/01/15, 12/31/15, UDI/Serialization on medical devices to end-user., 01/01/13, 12/31/14, Implementing a new design strategy for GMP packaging materials., 01/01/13, 12/31/13, Develop a new leaflet to a joint product between SSI and GSK, in close cooperation with GSK Regulatory Affairs department., 01/01/11, 12/31/12, Optimizing storage facilities according to GMP and just-in-time deliveries., 01/01/11, 12/31/11, Optimizing cooling pallets shipments according to WHO standards., 01/01/11, 12/31/11, Develop a new children's vaccination card to Greenland in close cooperation with the government / Medical Department in Greenland.

• Deviation (new set-up from nonconformities), 2018
• John Lee course (Understand FDA regulations), 2016
• Change Request - CR owner and action owner (in QA position), 2016
• Nonconformities - NC owner and action owner (in QA position), 2016
• CLEAN Basic, 2015
• GMP Documents Handling, 2014

• Relocation: Will move for the right position
• Title: Ms.

• Travelling - love to explore
• Motorsport

• Created a new vaccine card for Denmark and Greenland. Translation in cooperation with government secretary of Greenland.

• LEAN
• Six Sigma