GCP Auditor - 18month freelance contract

  • Fosters a commitment to quality in individuals and a culture of quality within the organization.
  • Work is performed under limited supervision. Minimal instruction is required only occasionally. Establishes and implements new tools as necessary. 
  • Coordinates and reviews the work of others. 
  • Manages and/or leads others in both routine and complex audit activities involving multiple projects and is responsible for ensuring activities are completed. 
  • Identifies, defines and communicates audit plans for contract auditors and oversees the activities performed by contract auditors. Trains contract auditors in company procedures. 
  • May establish relationships and agreements with contract auditors. 
  • Evaluates departmental and business area SOPs for fit for purpose and in compliance with regulatory requirements. 
  • Leads intra- or interdepartmental teams of an operational nature such as: preparing the Company for minor changes in regulations, continuous improvement initiatives 
  • Purpose is for input and obtaining information for dissemination intra- or interdepartmentally. 
  • Assists in readiness for and regulatory agency inspections. Assists in the coordination of responses to any regulatory agency findings. 
  • Developing and presenting training using standard modules and training on special topics
  • Ensures appropriate content of training modules 
  • Initiate operational change where required and communicate change in a positive manner. 
  • Considers a number of factors in planning, anticipate work and prioritize work to meet tight timelines. 
  • Direct others in prioritizing their work. 
  • Define systems or processes to consistently ensure the high standards required in Compliance. 
  • Effectively delivers messages to all audiences. 
  • Considers needs and level of audience in communication. 
  • Uses logical persuasion in discussions and presentations. 
  • Determines efficient and appropriate method of communication. 
  • Understands impact of decisions and actions on business and consults with appropriate colleagues and management as applicable 
  • Promotes and maintains productive working relationships. 
  • Mentors others in establishing good working relationships. 
  • Must have an in depth knowledge of regulatory requirements for assigned territories. 
  • Is recognized as a knowledgeable resource within the department and from other departments on a range of topics and someone whose opinion is sought as a regulatory resource. 
  • Understands current global and regional trends in regulatory compliance.

LOCATION

Office based West London (flex from home available)

DURATION

18 month contract (freelance)

SALARY

Competitive daily pay rate

ABOUT PLANET PHARMA
Planet Pharma is an American parented Employment Business/Agency that provides global staffing services with its head-quarters in Chicago and our EMEA regional office located in Central London. We have invested significantly in creating a robust international platform that enables us to work compliantly in 30+ countries with a current network of 2500+ active contractors globally as well as a very strong permanent / direct hire recruitment offering. 

Our specialist knowledge and close relationships with our clients and the wider industry really makes us unique in our field. Just recently we were recognised by FORBES as the 17th best professional staffing firm, and have won multiple awards from industry accredited bodies for our commitment to excellence and service delivery. We have extensive functional expertise including: Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions experts, Clinical development, Quality, Biostatistics, and Medical Affairs / Writing.

We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age.

www.planet-pharma.com

TO APPLY

If you would like to discuss this vacancy further or to discuss your career options in confidence, please telephone Sam Chapple on +44 (0)203 868 8607 or e-mail on schapple@planet-pharma.co.uk

If this role isn’t suitable for you, please let us know if you can refer anyone – any recommendations are much appreciated! Planet Pharma offers a competitive referral scheme so you will be rewarded for your help!

 

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