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Process Transfer Manager - Medical Devices 13485

Job Title: Process Transfer Manager - Medical Devices 13485
Contract Type: Permanent
Location: Manchester, Greater Manchester
Industry:
Salary: Excellent Benefits
Start Date: ASAP
Reference: J895724_1530264452
Contact Name: Lauren Ellis
Contact Email: admin@russell-taylor.co.uk
Job Published: June 29, 2018 10:27

Job Description

Our Client is a leading developer, manufacturer and supplier of premium molecular diagnostic products and services that are used to diagnose human diseases, and to aid in biomedical research. They are also a leader in development, manufacturing and sales of medical imaging systems and biopsy devices as well as surgical and treatment products, with an emphasis on serving the healthcare needs of women.

JOB SUMMARY

  • Responsible for the support of launched/approved products and operations processes and the creation and transfer of manufacturing processes from R&D to Manufacturing and site to site transfers of on-market products.
  • Responsible for the development of LEAN processes by the removal of waste and continuous improvement of existing process.
  • Responsible for the development of new processes, transfer to manufacturing and continuous improvement of existing processes.
  • Provide process support to Manufacturing and other Operations Groups.
  • Responsible for Pilot & Development Manufacturing activities, Scale-Up of production processes as the production demand dictates.
  • Provides the support needed to complete Process Validation activities and training of manufacturing staff during the validation cycle.
  • Directs Subordinates to complete assignments using established guidelines, procedures and policies. Monitors daily operations of the Process Transfer Department.

ROLE ESSENTIAL DUTIES AND RESPONSIBILITIES

  • Ensures team actions and deliverables are completed to the required due dates and project timelines.
  • Works collaboratively to problem solve with other departments.
  • Performs document review and approvals for the department.
  • Operates effective performance management of the Process Transfer team setting appropriate and business aligned goals, reviewing against expectations.
  • Provides guidance and development opportunities for team members.
  • Develops validation strategies for projects and agrees with the responsible member of Quality Engineering.
  • Contributes to department budget creation and ensures that department expenditure is within or below expectations.
  • Assigns and determines the team workload and priorities.
  • Oversees the development inventory locations and development production activities
  • Produces notebook, development, pilot and production materials
  • Oversees ERP real time transactions.
  • Reviews and independently generates notebook studies, technical reports, development and manufacturing documents.
  • Oversees and executes process validation of new and existing manufacturing processes
  • Represents Process Transfer on one or more core teams.
  • Provides the main point of contact and participates on behalf of Process Transfer in FDA and ISO lab audits.
  • Assists with troubleshooting experimentation required for projects.
  • Troubleshoots complex manufacturing process problems.
  • Oversees the development of manufacturing processes for transfer to Manufacturing.
  • Trains Manufacturing Operators on newly developed procedures.
  • Support the Technical Writers by contributing to manufacturing work instructions, area guidelines, knowledge base topics, style guides/templates, & department SOPs.
  • Reports periodically to management on project progress and status.
  • Provides technical support to Operations groups
  • Responsible for the Engagement plan and execution for the Process Transfer team.
  • Drive Value Improvement Project initiative for the team.

REQUIRED SKILLS

  • Typically requires BA or BS and experience desired
  • Working knowledge of experimental design.
  • Advanced knowledge of current GMPs.
  • Blood Borne Pathogen training.
  • Interpersonal skills
  • Technical skills
  • Work under own initiative and uses own judgment
  • Works collaboratively
  • Builds working relationships
  • Problem Solving
  • Proficiency with MS Word and Excel.
  • Strong math skills.
  • Applied knowledge of Technical writing.
  • Experience with presentation skills.

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