Change Control Coordinator - Japanese speaker required

RESPONSIBILITIES

• Oversight of process from SME assessment, SME Signature to QA Approval
• Follow up before due date.
• Follow up and escalation for overdue records.
• Change control review meetings in collaboration with PPM (IC)
• Scheduling and running Global Change Control Forum (KPI review with Stakeholders) – At least quarterly Preparation of monthly report on performance and overdue records.
• Coordinating monthly drop in session for changes
• Coordinating AdHoc meetings - To discuss how to progress changes that are held up in system
• Support RSR process (creation and progression of records in ARBR system)
• Support communication and follow up with issues related systems
• Support Change Control Working team with progression if CCCP records
• Update and maintain Product list
• Update and maintain Assignment list
• May act as Assessment Coordinator in TrackWise

QUALIFICATIONS

• Ability to speak and write Japanese
• Confident Communicator with good inter-personnel skills
• Well organised
• Familiarity to use of TrackWise (preferable)
• Working in GxP environment within a Quality function
• Coordinating activities being performed by multifunctional stakeholders.
• Leading meetings and facilizing issue resolution
• Managing change controls (preferable)

LOCATION

Fully homebased (anywhere UK)

DURATION

6-12 month contract

SALARY

Attractive salary plus bonus

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. Planet Pharma is an Employment Agency providing Global Staffing services.

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 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!