Qc Stability

1 month ago

Liverpool, United Kingdom Seqirus A CSL Company Full time

This role will support the site stability program by effectively coordinating the process from start to finish with focus to the ICH guidelines. Responsible for the day-to-day requirements relating to the site stability program including protocol/report authoring and data analysis/trending.

**Responsibilities**:

- To author stability protocols, interim reports, and reports for stability studies. This includes routine campaign stability studies and non-routine project stability studies.
- Management of stability studies in accordance with internal procedures, ensuring studies are set up per the protocol. Will liase with relevant QC laboratories to ensure stability samples are tested within their specified time frame.
- Trending of stability data through data table management and trend analysis utilising specialist software. To escalate any trends to the QC Stability Team Coordinator and support any investigations as required. Will support the business in requests relating to stability data (including, but not limited to temperature excursion assessments, regulatory requests and investigational work).
- To own and support stability related Deviations, CAPAs and Change Controls, and progress department improvements as appropriate.

Qualifications:

- Science related degree
- Proven GMP background in the pharmaceutical industry
- Experience of Quality Control testing techniques and industry practices
- Proven time management skills for planning and schedule of work
- Proven communication skills both written and verbal
- Strong Microsoft excel skills
- Analytical Mindset
- Science related degree
- Exp in data trending / software packages (JMP) desirable

This is an 18 month FTC

Our Benefits

CSL Seqirus is committed to attracting and retaining world-class employees who are valued for their contributions to achieving business objectives. Learn more about some of the

benefits

you can participate in when you join CSL Seqirus.

About CSL Seqirus

CSL Seqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. Learn more about CSL

Seqirus


We want Seqirus to reflect the world around us

As a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about

Diversity & Inclusion

at CSL Seqirus.

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