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GMP Document Coordinator

CV Consulting Ltd
Job LocationNottingham
EducationNot Mentioned
Salary12.00 - 15.00 per hour
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypeContract, full-time

Job Description

GMP Document Coordinator12-month contractStarting in October 2021Location: commutableNottingham can work from home but needs to be able to get to site twice a weekThe profile As GMP Document coordinator you will have a proven track record of ensuring that all activities required for the preparation of GMP manufacturing steps are complete in readiness for the planned work in accordance with the requirements of the management systems.The role

  • Liaising directly with Programme Technical Support Leads, Study Directors and clients to ensure optimised transfer of critical technical information to ensure smooth and seamless transition of manufacturing processes from Formulation Development to GMPmanufacturing.
  • Working closely with the project specific cross functional teams, including but not limited to Pharm Development, Analytical Development, Quality and Analytical QC and Project Management teams, to ensure timely and accurate preparation of Master Batch ManufacturingRecords.
  • Working closely with the Project specific cross functional teams to ensure timely and accurate preparation of supportive Quality Risk Assessments, Cleaning Technical Assessments, and training packs that are in place prior to onset of GMP Manufacturing activities.
  • Training the manufacturing team in study specific batch record completion.
  • Ensure that all work is conducted in responsible and safe manner in accordance with the company Health and Safety policies and ensure that all Health and Safety considerations are appropriately documented.
  • Raise and execute quality system documentation (e.g. deviations and change controls) in line with agreed procedures and project specific requirements.
  • Maintain personnel training record at all times and proactively identify any training requirements for the job role.
  • Demonstrate a high level of flexibility to support the business needs and our clients requirements.
  • Periodic review and update of Standard Operating Procedures and Working Instructions to ensure continued compliance with the Pharmaceutical Quality System.
Manage expectations of key stakeholders through proactive communication of issues, concerns and remediation activitiesThe Company:This is a wonderful opportunity for someone to gain or build upon their experience in a commercial department in the pharmaceutical industry.

Keyskills :
RemediationDeviationsPharm

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