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Job Details

Analytical Development Data Reviewer

Company: Thornshaw Recruitment
Location:
Reference: KR9990
Closing Date: 14 Jan 19
Type: Permanent
Salary (£): Negotiable
Benefits:

Job Summary:

My client, a global pharmaceutical leader, have a vacancy for an Analytical Development Data Reviewer.

Requirements:

 

JOB PURPOSE:
•    To support Product Development and Clinical Supply. 
•    To review all data associated with developing, transferring or validating analytical test methods as applicable.
•    Reports directly to Analytical Development Team Leader in the R&D Analytical group

RESPONSIBILITIES:
•    To review all data associated with the development, transfer or validation of robust, sound analytical methods.
•    To review test methods, validation protocols and reports as applicable.
•    To prepare submission documentation in support of license applications.
•    To take part in /lead Laboratory Investigations.
•    To attend internal project review meetings as required. 
•    To assist in the preparation for customer/ regulatory inspections.
•    To identify and make recommendations for improvements as part of a team within or outside the department in order to ensure continuous improvement.
•    To review raw data from the testing of raw materials, in-process samples and finished products in a timely & efficient manner to ensure quality and efficacy of the product.
•    To ensure that all work carried out is in compliance with the required standards conforming to company, cGxP, SOPs, regulatory regulations and guidelines, safety and environmental guidelines.
•    To review all data to ensure that it is completed correctly, in line with data integrity guidelines, free from errors, omissions or defects in order to achieve a high level of customer service and cGMP.
•    To perform additional team tasks as agreed to support effective running of the Business.
•    To support all other on-going laboratory functions & requirements.
Health and Safety:
•    To ensure the requirements of Company’s Safety Statement are implemented.
•    To continuously promote a positive safety culture by leading by example.
•    To implement safety requirements as per site documentation including SOP’s, Safety Statement and COP’s.
•    To report any defects/hazards

MINIMUM QUALIFACTIONS & EXPERIENCE:
•    Qualified to a minimum of degree level in chemistry, pharmaceutical science or a related discipline.
•    At least five years’ experience working in a related technical environment.


SKILLS AND COMPETENCIES:
•    Strong analytical ability and quality orientation.
•    Broad understanding of regulatory requirements for submission of dossiers in EU, USA, Japan and other jurisdictions
•    Knowledge of Project management skills
•    Proficient in the use of HPLC & associated problem solving.
•    Working knowledge of Empower laboratory software.
•    Proficient in dissolution testing
•    Proficient in the use of electronic document management systems.
•    Proficient in Technical report writing 
•    Strong Safety awareness.
•    Knowledge & proficiency of Microsoft products for example MS Excel, Word & Project, Power-point.

For further details on this vacancy contact Katie at +353 1 2784671 or email your CV to kruddock@thornshaw.com.   Log on to www.thornshaw.com for a full list of available vacancies.   Thornshaw is a division of the CPL Group

#THR2018

Apply for this job: Analytical Development Data Reviewer

Contact Information:

Address:  Head Office
Barton House 6 Old Dublin Road Stillorgan Co. Dublin

Rep. Ireland
Tel:  00 353 (1) 278 4671
Fax:  00 353 (1) 278 4672
Website:  Visit Our Web Site

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