Documentation Officer

Job Summary:

12 Month Fixed Term Contract - Documentation Officer - Competitive Salary - 3 years + experience
Requirements:

Title: Documentation Officer

Location: Middlesex

Job Accountabilities:

Reporting directly to the Head of Quality Control & Analytical Development
Working as part of the QC & Analytical Development Department.

Experience

Must have 4 years experience in a similar role preferably.

Job Content:

DAILY DUTIES AND RESPONSIBILITIES (NOT LIMITED)

Testing of drug products as per approved specification and MOA.
Thorough checking and review of analysis raw data and QC work sheet generated during analysis as per approved specification and MOA and its compilation.
Verification of assay, RS, dissolution and other tests calculation excel sheet (hard & soft copies) for correctness.
Specification, MOA, SOP & QC work sheet preparation, implementation and periodic review for revision.
Project related raw data management and filing (soft & hard copies).
Technical report writing & review before submission to regulatory authority.
Stability protocol preparation, data evaluation, overview preparation and report writing.
AMT protocol and report preparation and compilation.
Awareness of cGLP & cGMP
Knowledge of ICH and other guidelines.
Knowledge of change control, incident report, deviation and OOS related to analysis.
Instruments calibration master schedule preparation and follow up.
Method validation protocol preparation.
Familiar with the use of EP/BP/USP pharmacopoeia.
Finished products COA preparation.
Maintenance of in-house WS, impurities and reference standards.

Job Knowledge, Skills and Experience:

Computer Literacy: knowledge of Microsoft Word, Excel and Outlook.
Diligent
Essential: Very good verbal and written English
Ability to work to tight deadlines without errors.
Good numeracy skills.
Good communication skills.
Well organised and efficient.
Good attention to detail.
Able to work under pressure.

NOTE: I am a senior recruiter within the industry across a number of job divisions for the pharmaceutical, biotech and CRO sectors. For a confidential and professional chat about your requirements/ career advice and the chance to register for free and receive weekly job updates, please call Alex on or email

If this role is not what you are looking for and you have experience in or are looking to enter the pharmaceutical, pharmacy, biochemical or other scientific fields, please still contact us anyway because listed here are only a selection of the many vacancies we have available.

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