বিবরণ : Local Manufacturing QA area specialist. সংস্থা : Novo Nordisk. অবস্থান : Dhaka
Are you passionate about improving patient lives? Do you have a strong desire to be part of a patient-centric company? Novo Nordisk Bangladesh is looking for a Local Manufacturing QA area specialist, based in Bangladesh to join our team. If you are ready for a life-changing career, apply now and be part of our mission to make a difference in the lives of patients!
About The Department
Novo Nordisk is a global healthcare company with 100 years of innovation and supervision in diabetes care. This heritage has given us experience and capabilities that also enable us to help people defeat obesity, haemophilia, growth disorders, rare diseases, and other serious chronic diseases. Headquartered in Denmark, Novo Nordisk employs over 60,000 people in 80 countries and markets its products in more than 170 countries.
You will be part of Local Manufacturing, a part of Novo Nordisk with more than 800 people which oversees manufacturing of Novo Nordisk products from 10 production sites around the world. We are currently ensuring product for 5.5 million patients and are expecting to more than triple that amount in the coming years especially through increased production at existing and new CMOs.
The position holder will be operating in Bangladesh from our local Contract Manufacturing Organization (CMO) in Dhaka, however, traveling to Denmark 1-2 times per year should be expected.
The position
This position directly reports to Senior Quality Manager (based in Denmark) as the Novo Nordisk QA areas specialist on-site at our CMO in Bangladesh which produce to local markets and for export to global markets. You will be acting according to the autonomy given from LM-QA Senior Manager, quality agreement, oversight procedures and according to EU GMP and local regulation.
The nature and scope of main accountabilities includes but not limited to:
- Review and status assignment of batch documents for manufactured products; Review and approval of batch records. Status assignment of finished products for market.
- Quality Assurance Oversight; Daily QA oversight at the local facility including frequent shop floor presence. Oversight of batch related activities such as batch release, participate in on-site full batch review, parallel batch review activities, process activities and verified state such as Change Control and Product Quality Review.
- Quality Assurance presence at the CMO facility, warehouse, production, and packaging lines. Perform periodic checks and spot checks in topics such as equipment calibration status, data integrity, qualification and validations status, aseptic behaviour.
- Handle deviations, change requests, etc, occurring during manufacturing (as defined in quality agreement); Review and approval of deviations and change request in collaboration with related parties. For deviations in charge of quality assurance (QA), ensure deviations are adequately investigated and solved to root cause, and that the link between corrective actions is clear.
- Support Local manufacturing projects when expanding and improving production capacity and quality. Preparation of project related documents. Quality assurance (QA) presence during project activities, and ensure compliance to local regulations and EU GMP.
- Bachelor’s degree in pharmacy, engineering, or other relevant technical/scientific academic fields.
- Minimum of 4 years’ experience within quality assurance and aseptic production as well as knowledge of EU good manufacturing practice (GMP) and some international experiences are required.
- Extensive qualifications within deviation/investigation handling and change request handling within aseptic manufacturing.
- Highly qualified within manufacturing.
- Good communication in English in both spoken and written.
We are a proud life-science company, and life is our reason to exist. We’re inspired by life in all its forms and shapes, ups and downs, opportunities. For employees at Novo Nordisk, life means many things – from the building blocks of life that form the basis of ground-breaking scientific research, to our rich personal lives that motivate and energise us to perform our best at work. Ultimately, life is why we’re all here - to ensure that people can lead a life independent of chronic disease.
Contact
Please send your CV online (click on Apply and follow the instructions).
Deadline
Until the completion of recruitment.
Applications will be screened on an ongoing basis, so you are encouraged to apply as soon as possible.
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.
