Walker Cole International is supporting a leading biotech organisation in the appointment of a Quality Systems Specialist at their modern manufacturing site in Scotland. This is an excellent opportunity to join a dynamic and fast-growing business working at the forefront of scientific innovation.
Key Responsibilities:
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Lead the implementation and improvement of site-wide Quality Risk Management (QRM) processes in alignment with ICH Q9.
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Maintain a central risk register and oversee risk reporting and mitigation planning.
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Facilitate cross-functional risk assessments using tools such as FMEA, FMECA, and statistical methods.
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Support audits and inspections by presenting quality risk and compliance strategies.
Candidate Profile:
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Experience within a GMP-regulated manufacturing environment, preferably in biotech or pharmaceuticals.
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Strong understanding of Quality Risk Management principles and regulatory expectations.
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Excellent communication and stakeholder engagement skills, with experience supporting audits.
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A degree or equivalent in a relevant scientific discipline such as Biology, Chemistry, or Pharmacy.
GMP / Quality / Risk / QRM / ICH Q9 / Quality Systems / Biotech / Pharmaceutical / FMEA / FMECA / Audit / Compliance / MHRA / Quality Management / Risk Assessment / Scotland / Quality Assurance / Life Sciences / QMS / Regulatory / Manufacturing
Contact Details:
WALKER COLE INTERNATIONAL LTD Recruitment Team
