Quality Control Release Officer

Helsinge Internet Agency Limited; Runcorn; On-site; GBP 36,000; Full time

Job summary

A leading company based in Runcorn is seeking a QC Release Officer to ensure product release compliance with cGMP and ISO standards. The role encompasses reviewing documentation, conducting investigations, and interfacing with various departments to uphold quality assurance protocols. Ideal candidates will possess a degree in a life science subject and relevant quality assurance experience, with a focus on aseptic operations and GMP knowledge.

Qualifications

• Experience in quality assurance or related functions in pharmaceuticals or healthcare.
• Desirable: Experience in aseptic operations and compounding activities.

Responsibilities

• Review batch documentation for product release compliance.
• Determine product disposition and support non-conformities investigations.
• Compile Certificates of Conformance and document quality assurance events.

Skills

Knowledge of GMP requirements

Experience in quality assurance

Aseptic operations knowledge

Education

Degree in a life science subject

Job description

Total Staff Services are recruiting QC Release Officers for our Client based in Runcorn.

Job Purpose

Reporting to the QC Shift Team Leader for day-to-day operational duties, the QC Release Officer is responsible for performing all necessary duties in relation to product release in compliance with the quality systems in place in accordance with cGMP and ISO standards.

Main Accountabilities

• Reviewing batch documentation as part of the product release process, in order to assess whether a product is compliant with a given specification
• Determining product disposition; either release to market or for further internal use, or rejection
• Supporting investigations of non-conformities that may impact upon the release process, product quality or compliance of the ASU facility
• Contributing to Team KPI's for QC efficiency and OTIF in relation to product release
• Contributing to the continuous improvement of all aspects of the quality system to ensure departmental objectives are met and compliance with regulatory requirements is consistently achieved for the ASU
• Compiling Certificates of Conformance as required to fulfil clients responsibilities to its customers
• Operating the Quality Assurance databases to ensure appropriate documentation of events and to support QA in publishing appropriate trends within the business
• Interfacing with other departments including attendance at meetings to ensure that the requirements of the Clients QMS are met
• Conducting additional duties as required to support colleagues in the effective execution of their duties
• Ensuring outsourced products are processed in a timely manner and made available for use with transactions performed on SAP
  
  

Experience & Qualifications

Degree in a life science subject or appropriate experience of working in a quality assurance or control related function within either the pharmaceutical/ healthcare or related industry

• Experience of aseptic operations is desirable, if possible aided by experience in aseptic compounding activities
• Good knowledge of GMP requirements specifically for manufacturing and control of aseptically produced products as laid down in the Orange Guide
  
  

This job description reflects the present requirements of the post. It is not intended to reflect the full nature of all the duties required of the post-holder. As duties and responsibilities change and develop the job description will be reviewed as appropriate and subject to amendment in consultation with the post-holder(s).

Hours of work are Monday to Friday 0700-1500/1500-2300 rotating weekly

Salary £35,722