Multiple Quality Assurance GPV/GVP & GCP roles in the Surrey area

Location: United Kingdom

SIRE® is the market leader in Life Sciences recruitment. We believe the recruitment market needs to gear up in technology and continuous innovation. We like technology, in a Life Sciences market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!Our client is a professional Pharmaceutical, Medical Devices and Biotechnology organisation, based in Surrey United Kingdom.

The Company

Multiple of our clients in the Pharmaceutical, Biotechnology and Medical Devices are looking for senior Quality Assurance GPV/GVP & GCP specialists.

Role Description

Quality Assurance GPV/GVP & GCP

Responsibilities

- Quality Lead for PV Clinical and Post-Marketing
- Consultation on quality and compliance
- Provide quality metrics and trending
- Plan, schedule, conduct or manage, report and follow-up audits
- Guidance in the development and revision of PV procedures
- Communicate audit findings and monitor PV compliance regulations
- Track, review, approve, assess the efficiency of Corrective and Preventive Actions (CAPAs) from audits and inspections
- Document, investigate, close and trend Non-Compliance issues
- Support the responsible of R&D processes and Compliance in reviewing and trending audit reports and quality issues
- Prepare and host to regulatory Agencies inspections
- Provide or facilitate compliance training to PV and vendors
- Evaluate PV quality system and processes for optimisation, robustness and continuous improvement
- Perform additional tasks related to QA

Requirements

- Minimum of 8 years of experience in auditing and a minimum of 4 years in PV processes (collecting, processing and communicating) for Clinical and Post-Marketing activities
- Quality, processes and compliance oriented
- Training and coaching experience
- Cutting edge knowledge of GVP, government regulations and guidelines (EMA, FDA, PMDA) pertaining to PV
- Solid knowledge of IT structure and information database system (such as Argus and Trackwise)
- Ability to write multiple projects and priorities
- Excellent communication, negotiation, customer orientation and interpersonal skills
- Demonstrated attention to detail, accuracy, excellent review and analytical skills in a fast paced environment
- Results oriented, accountability and delivery
- University Degree in Science (Ph.D. or Pharm.D. or MD preferred)
- Proven track record of effective communication and negotiation with coworkers and vendors
- Excellent writing and oral skills
- Ability to train study and functional teams and vendors
- Knowledge of the pharmaceuticals R&D, product development environments and pharmacovigilance processes
- Thorough knowledge of applicable regulatory and GVP requirements
- Knowledge of the quality assurance processes such as investigation, root cause analysis and risk assessment

Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Riko Arends.