Novo Nordisk is looking for new potential candidates to fill in for QA Manager position. If you currently looking for new healthcare job opportunities and qualified with the job desc, feel free to apply this job.
In this role, you will be the Local Quality Responsible Person. You hold the following roles: QBIQ administrator, Isotrain Training Coordinator, novoGlow system user (if necessary Expert), Local Records Manager. You are responsible for continuously updating the department list of external requirements, Novo Nordisk product evaluation and release in coordination with the distributor in case of temperature deviations.
You will coordinate repackaging activities, approve repackaging plan, approve/ guide distributor to approve batch documentation and perform/ guide distributor to perform batch release along with drafting /revise relevant QA procedures/local processes from internal requirements/local regulations and adhering to those mentioned.
You will be responsible for coordinating reviews and comments from internal stakeholders during creation/updating of QA procedures, selection/de-selection of QBIQ documents, following-up and closure of audit findings issued during HQ and local audits and conducting internal QA trainings during induction/cycle meetings/annual sales meetings and as relevant.
You will also be in charge of Handling of Deviation and Change Control, providing training and guidance for local users related to novoGlow systems and drive the process of QMR. You will be the owner of Quality Agreement, ensuring patient safety in MSB and undertake pharmacovigilance activities as assigned.
You are expected to collaborate with cross-functional departments, Business Area office, APAC office, International Operations and Global Teams in enhancing quality operations and achieving quality goals.
You must comply with Novo Nordisk principles and internal legal laws and to represent company's best interest. You will stay compliant with requirements of the business ethics; external compliance and to safeguard the confidentiality of company, patients, business plans, and strategies against third parties.
As an integral business partner, you are expected to invest significant time and effort in supporting and working alongside affiliate colleagues of all levels across the region.
What we offer:
Working at Novo Nordisk
At Novo Nordisk, we strive for excellence. You share the same passion and commitment as our employees in our journey to make a difference to patients' lives. In exchange, we offer you the chance of a lifetime to work with extraordinary talent and benefit from unmatched opportunities for professional and personal development.
To be qualified, post graduate degree in Quality/Pharmacy/Lifesciences or related field. A minimum of Bachelor's degree is a must. You should have at least 3-5 years of experience in quality with understanding of Pharmacovigilance activities. Understanding of Regulatory affairs is an added advantage but not mandatory.
You should demonstrate broad knowledge and understanding of the pharmaceutical industry, preferable in Malaysia, Singapore, Brunei context. Thorough knowledge and experience with Quality and Quality Management Systems is necessary.
You should have strong stakeholder management skills along with excellent experience in change management.
Headquartered in Denmark, Novo Nordisk employs approximately 37,200 employees in 76 countries, and markets its products in more than 180 countries.
Novo Nordisk’s B shares are listed on NASDAQ OMX Copenhagen (Novo-B). Its ADRs are listed on the New York Stock Exchange (NVO).
How To Apply
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