Quality Assurance Officer
Location: East London
Salary: Up to £27,000 + Benefits
Hours: Monday to Friday 37.5hpw
Job Type: Permanent
- 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
- 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
- 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
- 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
- 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