QA Specialist
6 months ago
QA Specialist - Biopharmaceutical - Slough
We are looking for an experienced QA Specialist for a fantastic 12 month contract based in Slough.
Working with our client, a global biopharmaceutical organisation committed to improving the lives of people afflicted with neurological and immunological disease, you will be the HPQE in GCSO quality and compliance infrastructure development.
This is a superb opportunity if you are looking to advance your career in the field with a supportive and innovative company that will put you first.
**Responsibilities**:
Assist with creation/revision of appropriate quality and compliance policies, Standard Operating Procedures (SOPs), processes, and best practices as needed.
Work in collaboration with Clinical Development Quality, Patient Safety, Regulatory Affairs, strategic partners, and other stakeholders to ensure compliance with International Council for Harmonization of Technical Requirements for Pharmaceutical for Human Use (ICH) GCP, GLP, PV and relevant local and international regulations and to ensure inspection readiness.
Participate in Audit and Inspection planning with Clinical Development Quality and Pharmacovigilance Quality Assurance.
Represent or ensure GCSO representation and preparation during audits/inspections (on-site by internal and external parties).
Attend improvement initiatives to improve quality and compliance processes and effectiveness in collaboration with stakeholders.
Stay abreast with GCP, GLP, regulatory, and industry trends. Share key information gathered via professional associations and conferences (upcoming regulations, best practices) within the GCSO Practice, Global Regulatory Affairs, and Clinical Quality Assurance.
Provide relevant GCP, GLP, and PV guidance and training to GCSO staff for all phases of clinical drug development.
Partner with colleagues/others to (proactively) identify and mitigate compliance risks, resolve potential compliance observations and escalate critical compliance risks to Clinical Quality Management Lead.
**Required experience**:
Several years of pharmaceutical experience, preferably in a global Quality Assurance or a Clinical Development setting.
In depth experience of GCP and GVP, including hands on experience in global GCP audits and/or inspections.
Couple of years of experience in SOP writing essential.
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