Quality Officers

1 week ago

Pontypridd, United Kingdom Just Life Sciences Full time

Just Life Sciences are seeking 4 Quality Officers to join a Global Pharma company, on a shift pattern of Mon to Fri, 6am to 2pm one week and then 2pm to 6pm the next alternating, this shift pattern entitles you to a £3k pay uplift on the advertised salary.

Being with the production and manufacturing lines, you will

The main purpose of role:

- To assist the Quality Management team in ensuring that all activities on sites are in compliance with current Good Manufacturing Practice standards in accordance with company policies to meet business requirements.
- To work with primarily, the Manufacturing and Packaging departments to provide QA guidance and expertise in the resolution of quality issues.
- To ensure the timely release of product by the review of the critical process parameters of the batch documentation to assess the quality, safety and efficacy of the products prior to Qualified Person certification, in accordance with agreed schedules andService Level agreements.
- To perform process and departmental audits against the relevant GMP standards to ensure continued compliance and improvement of systems and processes.
- The job holder is responsible for the interpretation of GMPs for all manufacturing and packaging areas, including development and distribution stages with support from the Head of Quality and Site QP’s
- The key responsibilities include a Level 1 and Level 2 tiered system. With Level 1 officers being able to perform their own and Level 2 tasks competently.
- Technical/Quality Assurance

Level 1:

- To perform site wide self-inspections and promote continuous improvement across all disciplines.
- In conjunction with Operational departments, critically assess deviations and customer complaints to ensure closure in a timely manner.
- To perform batch documentation review (preferably in real time) of the critical process parameters of manufacturing, packaging and distribution operations to ensure compliance with written specifications, SOP’s GMP and GDP.
- Be fully competent to train others in batch documentation review of critical process parameters of the Manufacturing, Clinical and Packaging batches.
- To provide KPI’s for batch review and manage priorities/workload to ensure that batches are received and released in a timely manner to meet schedules, service level agreements and customer expectation.
- To ensure that following QA review that the batch is suitable for progression to the QP.
- Deliver GMP training to site.
- Respond to client requests and batch comments in a timely manner and measure/act on these metrics.
- To perform site wide self-inspections and promote continuous improvement across all disciplines.

Level 2:

- To perform Start up checks, Line clearance, In Process Checks and Finished Product Inspection in line with the production schedule.
- To gather data for Product Quality Reviews and trending of data.
- To gather KPI data on a monthly basis
- Approval/Inspection of labels
- Material checks prior to batch compilation
- Maintain the company pest control programme
- Continuous Improvement
- Review and improve departmental processes to strengthen key controls and eliminate waste.
- General/Other duties
- Ensure compliance to cGMP and SOPs throughout the company.
- To undertake such tasks and to manage specific internal or ad hoc projects as and when required to meet department and business needs and within the scope of the job-holder’s capabilities and responsibilities. Regulatory/Industry Responsibilities:

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