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Job Post Details

Quality Assurance Officer
Xeal Pharma Limited
Unit 1-3, Vauxhall Trading Estate, Dollman Street, Birmingham B7 4RA
From £27,000 a year
Permanent, Full-time

Job details

From £27,000 a year
Permanent, Full-time
Unit 1-3, Vauxhall Trading Estate, Dollman Street, Birmingham B7 4RA

Full job description

Job Overview
We are seeking a Quality Assurance Officer to support in our CBPM area of the business. This is an exciting opportunity to join a established and growth business. We are seeking someone to ensure compliance with statutory requirements, GMP & GDP guidelines and to implement the Quality Management System on behalf of and under supervision of Head of Quality.

Responsibilities

  • To formulate company Quality policy and establish a Quality Management System.
  • To investigate any queries if any non-compliance noticed.
  • To check accompanying documents e.g. Invoice and Certificate of Conformity for errors.
  • To take steps to correct any errors in the product or documentation.
  • To reject product if non-compliant with procedure is identified or quality is sub-standard.
  • To provide feedback to administration personnel for any errors identified in documentation and arrange for rectification.
  • To create batch sheets for new products.
  • To provide related advice to customers/colleagues.
  • To define manufacturing operations in association with Head of Production/Supervisor.
  • To define release criteria and limits of release.
  • To define specifications for raw materials, intermediates and finished products.
  • To audit and approve starting material suppliers.
  • To record items received at the Goods In station.
  • To release raw materials (APIs & Excipients) from quarantine after checking & filing Certificate of Analysis, MSDS, Manufacturing Quality Standard and TSE/BSE compliance certification.
  • To ensure QC testing of raw materials, approval of testing methods, sampling & other procedures.
  • To approve and monitor contract analysts.
  • To ensure all validations for equipment, facilities, processes and utilities are completed.
  • To ensure manufacturing-capacity capability is monitored.
  • To implement the required initial and continuous training of personnel in all departments.
  • To carry out internal audits.
  • To organise a product recall simulation, have knowledge of DMRC and contact numbers.
  • To archive manufacturing batch records.
  • To organise archiving of batch number books.
  • To have familiarity with HVAC systems and its operation.
  • To record internal incidents and implement changes through the CAPA system.
  • To record product-related complaints and investigate root causes.
  • To implement change control procedures as and when required.
  • To implement risk assessment protocols.
  • To read MHRA alerts on product recalls.
  • To carry out calibration of thermometers.
  • To have knowledge of all equipment that is required to be switched off and remain on permanently, at night.
  • To know about fire prevention.
  • To follow and have knowledge of all standard operating procedures.
  • To agree with any minor deviations in batch sheet before production.
  • To provide feedback to senior management.
  • To actively engage in continuous personal development.
  • Any other duties required to suit the needs of the company.

Requirements

  • Graduate in Pharmaceutical Sciences (BSc minimum).
  • Minimum of 6 months’ experience in a GMP pharmaceutical facility.
  • To have knowledge of Quality Management Systems, documentations such as Site Master Files, SOPs, change control, validation protocols, premises, equipment, starting material and finished product specifications, production, release and QC testing, environmental monitoring, internal & external audits and orange guide.
  • An individual with great attention to detail and appreciation of the concept of quality, consistency and strict adherence to procedures and systems.
  • Intuitive learner who can put into practice new skills and information learnt, enabling the business to make prompt and responsible decisions.
  • Able to use information effectively by collecting, analysing and collating necessary facts, figures and opinions using a range of sources.
  • Learns from opportunities presented by change and ensures that expertise is up to date, in order to provide best possible service and ensure customer can rely on advice.
  • Delivers courteous and prompt service. Is able to work independently and also part of a team by prioritising work flow.
  • Develops an understanding of individual customer and colleague needs and concerns. Is able to take personal responsibility for resolving concerns & issues.
  • Strives to exceed customer and colleague’s expectations.
  • Provides timely advice to help customers understand their own needs and can explain the benefits of a product or service.

Job Types: Full-time, Permanent

Pay: From £27,000.00 per year

Work Location: In person

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