

A leading organisation in the pharmaceutical industry is seeking a Senior Process Quality Excellence Specialist for a 12-month contract based in the Berkshire area. As the Senior Process Quality Excellence Specialist, you will play a crucial role in managing Regulatory Intelligence requirements.
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:
1. As the Senior Process Quality Excellence Specialist, you will act as the RIN coordinator, collaborating with Subject Matter Experts (SMEs) to ensure regulatory and guidance requirements are met in controlled documents.
2. As the Senior Process Quality Excellence Specialist, you will review regulations and identify appropriate SMEs based on the topic, ensuring compliance with regulatory standards.
3. As the Senior Process Quality Excellence Specialist, you will serve as a point of contact to confirm that Contract Research Organisations (CROs) have assessed regulatory and country-specific regulations impacting their Standard Operating Procedures (SOPs) and company studies.
4. As the Senior Process Quality Excellence Specialist, you will work with the Auditing team to host and coordinate internal Quality Audits, assisting SMEs in responding to audit queries and managing post-audit responses and Corrective and Preventive Actions (CAPAs).
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:
1. Relevant degree in a scientific or regulatory discipline.
2. Proven industry experience in regulatory intelligence and quality management within the pharmaceutical sector.
3. A working knowledge and practical experience with audit coordination and regulatory compliance.
Key Words:
Senior Process Quality Excellence Specialist / Regulatory Intelligence / RIN coordinator / Audit Host / Quality Audit / CRO / SOP / CAPA / Pharmaceutical / Compliance / #LI-DNI
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the Life Science sectors, combining recruitment expertise with scientific knowledge to help you advance your career.
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:
1. As the Senior Process Quality Excellence Specialist, you will act as the RIN coordinator, collaborating with Subject Matter Experts (SMEs) to ensure regulatory and guidance requirements are met in controlled documents.
2. As the Senior Process Quality Excellence Specialist, you will review regulations and identify appropriate SMEs based on the topic, ensuring compliance with regulatory standards.
3. As the Senior Process Quality Excellence Specialist, you will serve as a point of contact to confirm that Contract Research Organisations (CROs) have assessed regulatory and country-specific regulations impacting their Standard Operating Procedures (SOPs) and company studies.
4. As the Senior Process Quality Excellence Specialist, you will work with the Auditing team to host and coordinate internal Quality Audits, assisting SMEs in responding to audit queries and managing post-audit responses and Corrective and Preventive Actions (CAPAs).
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:
1. Relevant degree in a scientific or regulatory discipline.
2. Proven industry experience in regulatory intelligence and quality management within the pharmaceutical sector.
3. A working knowledge and practical experience with audit coordination and regulatory compliance.
Key Words:
Senior Process Quality Excellence Specialist / Regulatory Intelligence / RIN coordinator / Audit Host / Quality Audit / CRO / SOP / CAPA / Pharmaceutical / Compliance / #LI-DNI
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the Life Science sectors, combining recruitment expertise with scientific knowledge to help you advance your career.
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.
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