Documentation Officer (QA/QC)

Job Title: Documentation Officer

Location: Middlesex

Duration: ASAP - 12 month contract

The Client: Global Pharma company

Benefits: Competitive Salary and benefits available - Full details available on application

The Role:

Testing of drug products as per approved specification and MOA.
Thorough checking and review of analysis raw data and QC worksheet generated during analysis as per approved specification, MOA and its compilation.
Verification of assay, RS, dissolution and other tests calculation excel sheet (soft & hard 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 and review before submission to Regulatory Authority.
Stability protocol preparation, data evaluation, overview preparation and report writing.
AMT protocol, report preparation and compilation.
Instruments calibration master schedule preparation and follow up.
Method validation protocol preparation.
Familiar with the use of EP/BP/USP pharmacopeia.
Finished products COA preparation.
Maintenance of in-house WS, impurities and reference standards.

Full details available on application

The Candidate:

Must hold a qualification in a pharmaceutical science i.e. Life Science (BSC/MSC).
Must have a minimum of two years of previous experience of working in both Quality Control and Quality Assurance departments.
Keeping up to date knowledge of current pharmaceutical guidelines i.e. MHRA, ICH, EMEA.
Strong IT skills (proficient in MS Office: Word, Excel and Outlook).
Extremely organised to deal with a variety of projects and able to prioritise conflicting demands.
High level of accuracy and good attention to detail.
Ability to work under pressure with multiple projects to strict on-going deadlines.
Excellent communication skills (oral and written) and interpersonal skills.

Application Details:

If your skillset is relevant for this role, please click to apply on the link below. However, if this role doesn't suit your current skill-set, please call Alex on for further advice.

Candidates must provide confirmation that they have valid and existing permission to live and work in the UK.

If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment process.

About Apex: Apex International are an honest, knowledgeable and niche agency who recruit for the pharmaceutical, biotech and CRO sectors in the UK and EU. We specialise in the areas of: Medical Information, Medical Affairs, Pharmacovigilance, Drug Safety, Regulatory Affairs, Clinical Research, QA & QC, Clinical Data Management, Health Economics, Marketing and Pharmacy (Pharmacists, Pharmacy Technicians and Dispensers). For a confidential and professional chat about your job requirements with an agency who are expert in the fields they recruit for, and for the chance to register for free and receive weekly job updates, please call on or email

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