QC Stability Analyst

2 weeks ago

Speke, United Kingdom Adecco Full time
6 Month Contract £18.40
Stability Coordinator - Would be suitable for a Science Graduate with initiative and ability to compile data and statistics.
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 liaise 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
Different qualifications or responsibilities may apply based on local legal and/or educational requirements.
Refer to local job documentation where applicable.
.
Please note that due to the high volume of applications, only shortlisted candidates will be contacted. Thank you for your understanding.
Adecco is a disability-confident employer. It is important to us that we run an inclusive and accessible recruitment process to support candidates of all backgrounds and all abilities to apply. Adecco is committed to building a supportive environment for you to explore the next steps in your career. If you require reasonable adjustments at any stage, please let us know and we will be happy to support you.
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