Quality Assurance Operator
Posted 1 month ago - Expires in 24 days

Sheffield, South Yorkshire,
Permanent Full Time
£17000 to £18000

Quality Assurance Operator - Doncaster

Role: Quality Assurance Operator


Salary: Up to £18000 per annum

Location: Doncaster

Hours: Mon – Fri, 07:30 – 15:30

Our client is one of the UK’s largest wholesalers offering a product range through exceptional customer service and efficient delivery.

Job Purpose:

To ensure Master BPR’s are created in line with demands of the business.
To ensure that the Quality Assurance is working efficiently, that controls on components, products and environment are carried out and documented in a timely manner and high levels of quality are maintained.
To carry out and document controls on components, products and environment in a timely manner and maintain high levels of quality.
To assist in other Quality Assurance activities as requested.

Key Responsibilities:

Creating Master Batch Packaging Records (MBPR’s) in accordance with the product licence, prior to formal sign-off. Maintain the BPR log.
Report any issues affecting BPR’s to the Production Manager/Commercial Regulatory and provide assistance (liaising with other departments as necessary) so they can be resolved in timely manner.
Pair the stock to the relevant MBPR and create job bag documentation for the production team.
Conducting pre-production checks e.g. correct product, label and leaflet
Conducting post-production checks. Ensure stock has been labelled correctly.
Carry out specified controls on each product repackaged and the packaging materials used and record them in the appropriate documents in a timely manner.
Be proactive and resolve or seek assistance to resolve Quality Assurance problems.
Adhere to GMP, Standard Operating Procedures (SOP’s), Work Instructions (WI’s), rework procedures, policies and other relevant guidelines and approved documents at all times. Ensure others are following the SOP’s and WI’s etc.
Detect deficiencies in current practices and controls and report them to the Production Manager/Commercial Regulatory.
Maintain Quality Assurance records and in compliance with Good Documentation Practice.
Report sickness and unexpected absences and seek approval of holidays as soon as possible to minimise impact on the running of the department.
Be competent with MS Office and implement, update, maintain and review the in-house electronic databases.
Resolve, or provide assistance to resolve problems affecting in creations of master BPR’s. Assist other departments as required.
Communicate with Production Manager/Commercial Regulatory to resolve any issues/queries relating to the Master BPR creation.
Participate in any reasonable task requested by the Production Manager/Commercial Regulatory
Report any occurrences with potential impact on patient safety and/or product efficacy and/or quality to the Production Manager and Commercial Regulatory.
Report to the Production Manager and Commercial Regulatory any problems hindering the efficient running of the department.
Assist in maintaining a safe and clean working environment.
Provide mentoring, training and leadership to the QA Operators via training, competence assessments, performance reviews and conflict management.
Ensure all staff remain up to date with changes to procedures and are able to perform to the required standard.
Play a key part in progressing the investigation and correction of production related abnormalities/ deviations in accordance with the defined procedures.
Highlight process and procedural deficiencies and recommend remedial actions via the change control process.
Ensure that Quality Assurance records and logs are kept up to date in accordance with good documentation practice.
Highlight any observed process or procedural issues which could adversely affect quality or compliance and progress remedial actions in accordance with defined processes.
Monitor the quarantine area and associated stock movements and maintain the register. Progress any products for re-work as appropriate.
Report any issues/damages affecting calibrated instruments used within the Quality Assurance department.
Assist in maintaining a safe and clean working environment.
File records in an organised and secure manner.
Place products and retrieve products from the Quality Assurance Quarantine area after obtaining approval from Commercial Regulatory and completing the relevant log.

Key skills required for this role are:

Excellent attention to detail
Excellent Microsoft Word & typing skills
Knowledge of Microsoft packages such as Word, Outlook and Excel
Be able to communicate and work effectively
Be flexible to suit the needs of the business

Manual Handling:

It should be noted that manual handling task such as lifting and bending are “essential requirements” of this role.

Glu Recruit are an equal opportunities employer.