Senior Process Quality Excellence Specialist
Posted 1 day ago by Hyper Recruitment Solutions
Negotiable
Undetermined
Undetermined
England, United Kingdom
Summary: The GCP Quality Specialist role at a leading pharmaceutical company in Berkshire involves developing and maintaining clinical quality systems and ensuring compliance with regulations. The position requires collaboration with various stakeholders to mitigate quality risks and prepare for inspections. The specialist will also provide training on Good Clinical Practice and related regulations. This role is essential for maintaining high standards in clinical quality and compliance within the organization.
Key Responsibilities:
- Support the Head of Process Quality Excellence in developing and maintaining clinical quality systems and procedures.
- Collaborate with Global Quality, Patient Safety, Regulatory Affairs, and other stakeholders to ensure compliance with international regulations and inspection readiness.
- Lead GCSO Inspection Readiness Activities and participate in audit and inspection planning.
- Provide guidance and training on Good Clinical Practice (GCP), Good Laboratory Practices (GLP), and Pharmacovigilance (PV) to staff.
Key Skills:
- Relevant degree in a scientific or related field.
- Proven industry experience in clinical quality and compliance.
- GCP experience is a must.
- Experience as a Clinical Project Manager with QMS experience or as a Quality/QA professional with strong experience in Clinical/GCP.
- Working knowledge and practical experience with GCP, GLP, and PV regulations.
Salary (Rate): undetermined
City: undetermined
Country: United Kingdom
Working Arrangements: undetermined
IR35 Status: undetermined
Seniority Level: undetermined
Industry: Other
We are currently looking for a GCP Quality Specialist to join a leading pharmaceutical company based in the Berkshire area. As the GCP Quality Specialist, you will be responsible for developing and maintaining clinical quality systems/procedures and ensuring quality and compliance risks are appropriately identified and mitigated.
Key Duties And Responsibilities
Your duties as the Senior Process Quality Excellence Specialist will be varied; however, the key duties and responsibilities are as follows:
- As the GCP Quality Specialist, you will support the Head of Process Quality Excellence in developing and maintaining clinical quality systems and procedures.
- As the GCP Quality Specialist, you will collaborate with Global Quality, Patient Safety, Regulatory Affairs, and other stakeholders to ensure compliance with international regulations and inspection readiness.
- As the GCP Quality Specialist, you will lead GCSO Inspection Readiness Activities and participate in audit and inspection planning.
- As the GCP Quality Specialist, you will provide guidance and training on Good Clinical Practice (GCP), Good Laboratory Practices (GLP), and Pharmacovigilance (PV) to staff.
Role Requirements
To be successful in your application to this exciting role as the Senior Process Quality Excellence Specialist, we are looking to identify the following on your profile and past history:
- Relevant degree in a scientific or related field.
- Proven industry experience in clinical quality and compliance.
- GCP experience is a must.
- A Clinical Project Manager with QMS experience (Editing and writing SOPs, Quality site management etc), or an established Quality/QA professional with strong experience in Clinical/GCP would be suitable candidates.
- A working knowledge and practical experience with GCP, GLP, and PV regulations.
Key Words: Senior Process Quality Excellence Specialist / GCSO / Clinical quality systems / Good Clinical Practice / Good Laboratory Practices / Pharmacovigilance / inspection readiness / Audit planning / compliance policies / CAPA tracking / GCP
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the STEM sectors, combining recruitment expertise with scientific knowledge to help you advance your career.