QC Stability Coordinator

3 weeks ago

Speke, United Kingdom SRG Full time

Title - Quality Control Stability Coordinator
Location: Speke, Liverpool
Rate: £18.40
Contract - 6 months

SRG is working on an excellent opportunity for a Quality Control Stability Coordinator with industry experience to join a global-leading pharmaceutical manufacturer.

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
Experience in stability testing previously is desirable
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) desirableCarbon60, Lorien & SRG - The Impellam Group STEM Portfolio are acting as an Employment Business in relation to this vacancy

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