QA Specialist
- South East
- Contract
- Compliance / Quality Assurance
This vacancy has now expired
We are looking for an experienced QA Specialist for a fantastic 12 month contract based in Slough.
Working with our client, a global bio-pharmaceutical 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 Harmonisation 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.
- Support Corrective and Preventive Action (CAPA) activity for internal (system) audits and findings from any audits and inspections where findings are raised to our client in conjunction with department managers and subject matter experts. This includes CAPA tracking and monitoring for timely closure.
- 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.
If this role is of interest, please apply now.
#LI-JS4
I have always received a highly professional & personable service from the team at QCS Staffing. They listen carefully to the specific requirements of available roles and work tirelessly to supply a pool of potential candidates and make the hiring and contract renewal process an easy activity to manage.
Global Pharmaceutical firm
We have worked together with QCS Staffing for seven years now and have always received a professional service. QCS Staffing's speciality certainly lies within their technical sourcing abilities and they have met our demanding requirements time and time again. Coupled with this are the integrity of QCS Staffing's people and their ability to deliver.
Global Pharmaceutical firm
Once again can I via you recognise the superb support I was given before, during and after this short contract. The support, was as usual professional and every friendly.
QA Specialist
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