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Work as Quality Analyst(QA) Professional in Novo Nordisk

 

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Novo Nordisk is a global healthcare company with 89 years of innovation and leadership in diabetes care. The company also has leading positions within Haemophilia care, growth hormone therapy and hormone replacement therapy. Headquartered in Denmark, Novo Nordisk employs approximately 33,300 employees in 75 countries, and markets its products in more than 190 countries Novo Nordisk’s B shares are listed on NASDAQ OMX Copenhagen (Novo-B).

Post: Quality Analyst(QA) Professional

Job Desciption
Novo Nordisk is looking for an experienced QA professional to act as our QA oversight and QP delegate at the Torrent Insulin production facility at, Indrad, Gujarat. This position will report to Head - Regulatory Affairs, Quality & Medical Writing based at India and a dotted line reporting to Senior Manager CLM QA based at Denmark. Torrent manufactures human insulin products under contract for Novo Nordisk A/S. Torrent is responsible to ensure that the production facility and QMS system lives up to EU GMP and requirements in India.

About the department
CLM QA is part of Contract and Local Manufacturing (CLM) which is a unit in Devices & Supply Chain Management in Product Supply, Novo Nordisk A/S.CLM QA is responsible for quality assurance and quality support for production activities worldwide. This can be in the form of contract manufacturing arrangements or via local production set up involving the Novo Nordisk affiliates.The department is characterised by a high level of professionalism, flexibility and helpfulness.


 

The Job
In association with CLM QA in Denmark your responsibility will include release of packaging batches and acting as QA oversight. As part of the QA oversight task you will review documentation for production and support processes as for e.g.: on equipment, facility documentation and monitoring the EM/water trend also non-conformity handling incl. timeliness on handling of actions will be a part of the QA oversight.

It will be your responsibility to report QA oversight evaluation performed at Torrent facility both to Torrent Site Management and CLM QA in Denmark to ensure that quality tasks are reported and will be handled by Torrent management and CLM QA. You will Participate in: Visits from CLM QA at Torrent, NN Corporate audits within your field of responsibility, Compliance Board Meetings at Torrent, Torrent/CLM Meetings. Before starting up as a QA Professional at Torrent facility you will be trained by CLM QA in Denmark for handling batch documentation and other GMP tasks relevant for the position.


Qualification
You hold an academic degree as pharmacist, engineer or similar and have at least 4 years of experience from a pharmaceutical organisation where you have gained a solid and strong up-to-date knowledge of quality and EU GMP requirements.

You have thorough knowledge within activities related to aseptic production and/or quality assurance of either sterile/aseptic manufactured products or packaging processes.

You have good communication skills and you are able to organise and drive tasks. You take a pragmatic approach to problem solving and have strong interpersonal skills. You are detail-oriented with a strong quality mind set and are a team player, but also able to work independently. You thrive on working across departments in an international organisation. You are expected to be fluent in English.

We look for an open minded person with an outgoing attitude and, natural networking skills. Additionally we would enjoy having a straightforward person with a good sense of humour in our department.

Additional Information:
Qualification: B.Pharm, B.Sc
Location: Gujarat

Industry Type: Pharma/ Biotech/Clinical Research
Functional Area:  QA

Post Date: 15th September, 2015

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