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Job Details

Interim RA CMC consultant

Company: Hobson Prior
Location: Sweden
Reference: CM458184
Closing Date: 26 Aug 17
Type: Contract
Salary (£): On Application
Benefits: 300 SKR

Job Summary:

This role is working for the clients manufacturing network to ensure it has full visibility and access to the current regulatory approved Chemistry Manufacturing and Controls (CMC) dossier for each country where the product is marketed.

Requirements:

WWorking for a global pharma

 

This role is working for the clients manufacturing network to ensure it  has full visibility and access to the current regulatory approved Chemistry Manufacturing and Controls (CMC) dossier for each country where the product is marketed. This is critical in ensuring that products are manufactured in compliance with the licences held by the third party licence holder.

You will be joining a team of Regulatory system specialists within a global Operations Quality function

Typical accountabilities:

You will be responsible for:

The uploading of manufacturing documentation provided by external partner companies into an existing document management system,

Compliance with established good documentation practices such as document version control, ensuring business approval and document format will be part of this work.

Communication of any changes to this information, such as new market approved documentation, to the relevant manufacturing sites is also a critical success factor.

Additionally, you will be required to ensure that client's change control system is maintained to reflect regulatory assessments supplied by the third party.

You will responsible for the upload of documents provided by external partner and communicate to relevant manufacturing sites.

You will act as a key contact person for administration of documents related regulatory changes received from the external partner.

This is a new role and you will be expected to participate in the development of any processes required to achieve the above.

 

Essential requirements:

• Educated to degree level

• Strong IT skills, experience of document management systems preferable

• Self motivated and capable of working under minimal supervision

• Excellent communication skills (written and oral)

• High level understanding of GMP and working in a regulated environment

• High level understanding of CMC Regulatory knowledge

 

 

 

 

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Contact Information:

Address:  Hobson Prior International Ltd
Wellington Gate
7-9 Church Rd.
Tunbridge Wells
kent
TN1 1HT
England
Tel:  01892 612 612
Fax:  01892 612 613
Website:  Visit Our Web Site

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