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Documentation Analyst

Posted about 2 months ago

Location South Wales Job Type Temporary
Salary to £25,000 Sector Regulatory Affairs, Quality Management, Quality Assurance

Documentation Analyst

 

£21,000-£25,000

 

Temporary role (possibility of permanent)

 

South Wales

 

 

This is a temporary role to write high quality technical analytical documentation and to undertake analysis as required.

 

What you’ll do:

 

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  • The job holder is required to work on their own initiative and largely independently on key responsibilities under the supervision of the Documentation Team Leader.
  • The job holder is responsible for generating high quality analytical specifications ensuring consistent deliveries for technical documentation for work that falls within the Analytical Services group.
  • Assist in the analysis of data to help identify areas of improvement primarily within the department but also across the business where appropriate.
  • To interpret analytical data and generate comprehensive gap analysis, review reports, analytical protocols and reports in line with regulatory requirements and business proposals.
  • To generate comprehensive analytical methods that are easily understood by analysts and technicians at all levels.
  • To generate product and material specifications in line with customer and regulatory requirements.
  • To update all above named documentation in line with company procedures.
  • To ensure a consistent approach is taken to document writing and to ensure all protocols and reports are generated to a minimum of regulatory submission standard.
  • To generate accurate cost proposals and change orders in line with service level agreements based on information supplied by the business development group.
  • To review analytical and laboratory data within the department for accuracy, completeness and compliance with documented procedures.
  • To communicate effectively with internal and external customers and participate with them in problem solving activities, as required.
  • To assist in the analysis and presentation of departmental metrics data to aid in the selection of continuous improvement projects within the department and across the business where appropriate.
  • To participate in identified continuous improvement projects within the department and across the business as required.
  • To maintain a thorough understanding of international regulatory requirements pertinent to the team, and to ensure that all work within the team complies with these, with departmental procedures and the principles of Good Manufacturing Practice.

 

Your background:

 

We are seeking someone with experience in a pharmaceutical environment, you will have excellent technical writing skills as well as proficient MS Office / good standard of IT skills.

 

You will bring an in-depth understanding of method validation at different phases of development and previous experience in writing technical documentation

 

On this occasion, LiCa Scientific is acting as an employment agency

 

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