Specialists in Pharma, Clinical & IT Recruitment

Technical Specialist

Reference:
TSFTC
Job Type(s):
Quality Assurance, Regulatory Affairs
Salary:
Salary negotiable
Benefits:
Excellent Benefits
Town/City:
London
Contract Type:
Permanent
Date Posted:
14/11/2013 17:54:00
Start Date:
14/11/2013
End Date:
16/01/2014

Description

My Client a Global Generic’s company have opened 2 new vacancies within their Technical Division; they are actively looking to recruit 2 Technical Specialist to their team on a fixed term contract basis, to their offices in London.

MAIN PURPOSE OF ROLE:

Support and improve the on-going supply of difficult to make products through on-site support to contract manufacturers.

Provide technical services to Regulatory and quality, support scientific and technical due diligence as required and provide expert input in to MA/Manufacturing compliance.

Deliver specific projects that include site transfers, changes to API sources, reformulation and process improvement.

KEY RESPONSIBILITIES:

·        Provision of technical support and expertise to all relevant activities within the business unit

·        Project management of assigned projects

·        Authoring, review and approval of technical documentation (BMRs, technical reports and summaries ,etc.) to support manufacturing & regulatory activities

·        Authoring, review and approval of sections of Regulatory Dossiers (Module 2 and Module 3) in CTD format for use in all submission related activities

·        Management of and participation in, technical transfer activities with associated document authoring and review

·        On site attendance at manufacturing sites to resolve manufacturing/technical issues affecting continuity of supply of all products

·        Other tasks as delegated by Line Manager which contribute to overall running of the business unit

 

Skills/Experience Required

·         Strong Life Sciences Background

·         Excellent experience within Formulation Development

·         Knowledge of CMC

·         Prince 2 Experience nice to have.

·         Fluent in English.

For more information regarding this vacancy or a confidential job discussion, please get in touch with Neal Panting. Neal@arc-7.com or +441483 397070

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