We are recruiting a Senior Process Quality Excellence Specialist to join a leading Pharmaceutical company in Berkshire. This role offers the chance to make an impact by ensuring regulatory compliance and maintaining high-quality standards. As the Senior Process Quality Excellence Specialist, you will be at the forefront of managing regulatory intelligence and coordinating audits, providing a pivotal role in maintaining the integrity of controlled documents and ensuring compliance with regulatory requirements.
This position is an initial 12 month contract and can offer 3 days p/w remote working, 2 days p/w onsite.
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 manage the Regulatory Intelligence Network requirements for the Clinical GCP team, coordinating with SMEs to ensure compliance with regulatory and guidance requirements.
2. As the Senior Process Quality Excellence Specialist, you will act as the RIN coordinator, reviewing regulations, identifying relevant SMEs, and ensuring controlled documents are updated accordingly.
3. As the Senior Process Quality Excellence Specialist, you will serve as the point of contact for Contract Research Organisations (CROs) to confirm that regulatory and country-specific regulations impacting Standard Operating Procedures (SOPs) and studies are assessed.
4. As the Senior Process Quality Excellence Specialist, you will host and coordinate internal quality audits, working closely with the auditing team and relevant SMEs to respond to audit queries and manage post-audit activities, including responses to findings 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 related field.
2. Extensive industry experience in regulatory intelligence and quality assurance.
3. A working knowledge and practical experience with managing regulatory requirements and coordinating audits.
Key Words: Senior Process Quality Excellence Specialist / Regulatory Intelligence / RIN Coordinator / Quality Assurance / Pharmaceutical Industry / Audit Host / Controlled Documents / CRO / SOP Compliance / CAPA Management / Pharma / Biotech / Biotechnology / Pharmaceutical / CGT
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.