Medical Device Data Integrity Project Manager

Ashville, NC

Job ID: 127247 Industry: Med

 

Medical Device Data Integrity PM

Project Description:

Our client is a large Medical Device company currently looking to add a Project Manager to their tech operations group. They will be overseeing Computer System Validation (CSV)/Data Integrity (DI) gap assessment for lab and manufacturing systems. Need a candidate with experience in CSV or DI and qualification of laboratory equipment. The assessment must be completed by the end of the year. 

Responsibilities:

Our client is looking for a PM with strong Computer Systems Validation (CSV) background in the Medical Device or Pharmaceutical industries, minimum of 5 years of experience. This individual should have experience with data integrity principles, computer system validation, equipment qualifications, HMI/PLC interfaces, electronic records/signatures.

Must have experience with with project management, overseeing the qualification and operations in a cGMP environment within the laboratory. Direct experience in the execution of validation protocols. Knowledge of current industry standards such as GAMP5 and ASTM E2500.
  • Tactical thinker with experience working with testing, validation and/or quality strategies.
  • Excellent communication and documentation skills.
  • Good documentation / note taking skills & speaking skills.
  • Ability to understand and query where necessary to better understand current state. 

 Required Skills:
  • Project Management 
  • Computer Systems Validation (CSV)
  • Data Integrity
  • 21 CFR Part 11
  • cGMP - Laboratory Equipment (Chemistry or Micro)
  • GAMP5 

Job Type: Contact

Not ready to apply?

Send an email reminder to:

Share This Job:

Related Jobs: