Quality Assurance Officer |£26000 - £27000 per annum
Quality Assurance
Permanent
South East

Quality Assurance Officer

Additional Information

Location: East London

Salary: Up to £27,000 + Benefits

Hours: Monday to Friday 37.5hpw

Job Type: Permanent

Summary

  • To work with QPs and production operations to assist in driving continuous quality improvements.
  • To undertake batch review, prior to formal sentencing, for both licensed and unlicensed products, operating within both company and regulatory requirements.
  • To assist with investigations and report writing as needed within the business.
  • To support the assigned work stream leader to meet the company objectives.
  • To work within multidisciplinary teams as required by the business.

Main Responsibilities and Duties

Finance

  • To work with line management to investigate batch rejections and identify means to prevent a recurrence.
  • Looks for ways to maintain or reduce costs
  • Looks for ways to minimise batch losses and increase yields

Customer

  • To provide support to the work stream and assist in meeting the production schedule.
  • To work with the team and line management to deliver quality improvements
  • To support the QP and QA functions
  • To provide on line QA support of production operations

Process

  • Ensure Product Batch Cards are assessed in line with cGMPs
  • Ensure adherence to agreed SOP’s
  • Ensure adherence to batch processes
  • Participates positively in reviews to improve effectiveness and efficiency

People

  • Responsible for providing support to QPs for batch review / incident/deviation / issue resolution.
  • Considers own development opportunities
  • Supports and participates in learning through the training promise

Specific Departmental Functions

  • Ensure that all activities within the area are undertaken to established standards of cGMP.
  • Constantly drive to deliver high standards of GMP and general housekeeping
  • To assist in ensuring that all activities within the area are undertaken to established standards of cGMP.
  • Assist in internal/external quality audits. Ensure implementation of resulting improvement recommendations or compliance gaps, in accordance with the site Quality System process.
  • To assist in ensuring that all incidents, Deviations and Change Controls are reported and investigated with corrective actions completed to agreed timescales.
  • Work with other Stream members in developing reports on quality incidents e.g. deviations, batch failures, etc. to support the action taken and reflect the investigation and risk assessments undertaken
  • To undertake another tasks required for which training has been provided

Experience and Qualifications

A science degree or equivalent, preferably in pharmacy, chemistry or biological science.

Knowledge of Microsoft Office software.

2 – 3 year pharmaceutical industry experience

ERP software experience preferable

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