What are the responsibilities and job description for the Quality Assurance Specialist (GMP/Documetation) position at Infotree Global Solutions?
SUMMARY:
Job Details: Primary responsible for quality oversight of GMP documents related to site startup activities. Some of these activities include reviewing and approving GMP documents, communicating with site SMEs for document adequacy, communicating action progress to Sr Manager level. Skills: knowledge of process and facility equipment, ability to interpret and apply Good Manufacturing Practices (GMP); quality assurance or manufacturing experience in the pharmaceutical or medical device industry; written and spoken fluency required in English.
Top 3 Must Have Skill Sets:
Experience reviewing and approving GMP documents from a Quality role, experience working in a fast paced environment, ability to interpret and apply Good Manufacturing Practices (GMP)
Document management experience
Day to Day Responsibilities:
Manage GMP documents for review and approval as part of the start-up activities, communicate updates to Sr Manager level, and triage documents for adequacy
