Quality Assurance Officer

3 weeks ago

Marlow, United Kingdom Russell Tobin Full time

Quality Assurance Officer (Compliance) - Marlow (Hybrid) - 5 Months contract - upto £19.50 per hour Umbrella


Overview:

Reporting to a Quality Manager, provide day-to-day assistance for commercial QA activities associated with effective running of the site QMS supporting batch release. The QA Officer will ensure assigned tasks are performed in a timely manner to meet internal standards and all associated international GMP/GDP requirements.


Primary Duties:

• To assist in maintenance of quality systems including deviations/ exception reporting, change control, supply agreements, document control, quality metrics reporting, training as determined by the QA Manager.

• Complete scheduled records and quality system tasks in a timely manner and in compliance with internal standards and EU GMP.

• To compile & review Product quality review sets for completeness & compliance to EU GMP, client internal requirements and regulatory dossier submissions.

• Support in internal audits.

• Participate in Quality Risk Management (QRM) assessments.

• Project execution and support as required.

• Contribute to the completion of complex projects, manage own time to meet agreed targets and develop plans for work activities on own projects within a team.


Experience required:

• Basic experience in pharmaceutical manufacturing, distribution, and control measures. 2-3 years in a GMP environment.

• Basic experience in Quality administered systems. Previous use of TrackWise® QMS beneficial.

• Attention to detail and accuracy – able to follow verbal and written instruction (SOP’s).

• Excellent system skills – Word and Excel essential, experience with electronic documentation control systems advantageous.


Experience preferred:

• Sterile injectable manufacture

• Manufacture of novel dosage forms

• Secondary / outsourced packaging activities

• Global manufacture and supply chains

• New product launches & commercial supply chain

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