The PositionResponsible for the production activities & validation. Ensures relevant compliance issues are addressed & handled in close collaboration with production. Main duties include review of batch reports & release of API materials, deviations, change controls, review & approval of SOPs, QA presence & process confirmation on shop floor & improvement of Quality processes.
RelationshipsReports to Manager, Quality Assurance.
Essential Functions- Ensure that the current NN procedures & requirements from health authorities are reflected in the validation planning & quality related decisions
- Support validation projects in communicating Novo Nordisk project quality requirements & assessing suppliers' ability to support test/qualification activities to ensure that Novo Nordisk requirements & expectations are clear
- Support projects in solving quality related issues, act quickly in order to come to a decision, & communicate quickly & clearly regarding such decisions
- Support evaluation of the quality level during the project by performing spot checks of validation documentation
- Perform activities related to Batch review & release
- Review & approve API/Intermediate Batch documentation in various Novo Nordisk systems (e.g., LIMs, SAP, NovoGlow, etc.)
- Ensure site compliance with Regulations, ISO standards, & Corporate/Local SOPs
- Review & approve change control requests
- Review & approve deviations
- guidance to departments regarding quality & related activities
- Participate & provide input to root-cause analysis
- Participate in process confirmations & quality oversight
- Authorized person according to Novo Nordisk Quality Manual
- Other accountabilities, as assigned.
Physical RequirementsMay move equipment &/or supplies weighing up to 33 pounds within the facility using various body positions. May be required to be on your feet for up to a 12-hour shift. May required corrected vision to 20/20 or 20/25 based on role. May require colour vision based on role. May require the ability to work in loud noise environments with hearing protections.
Qualifications- Bachelor's Degree in Life Sciences, Engineering, or related field required
- Minimum of five (5) years of experience within the pharmaceutical industry required
- Good Knowledge of cGMP manufacturing & production processes & how to apply required
- Good Knowledge of the Batch review Processes required
- Good Knowledge of quality management systems required
- Good Knowledge of quality oversight & on floor production support required
- Strong knowledge level in cGMP's & validation required
- Strong knowledge in Quality Management Systems required
- Must be ability to perform tasks independently, accurately & within defined time frames required
- Ability to willingly work with customers/stakeholders in a cooperative manner required
- Strong written & verbal communication skills required
- Strong computer skills in MS Office, PowerPoint, Word, Excel, etc required
- Proven expertise in planning & organizing tasks preferred
- Willingness to assist others in developing plans in a cross-functional environment preferred
- Innovative approach to establishing priorities preferred
