QC Stability

3 weeks ago

Speke Merseyside, United Kingdom Adepto Technical Recruitment Ltd Full time

QC Stability & Support Coordinator – Contract – 6 Months – Merseyside - £18.40 p/h - Biotechnology 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. Day to Day

  • 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
  • Exp in data trending / software packages (JMP) desirable

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