Published date Posted on Indeed on Oct 25, 2021 (34 d ago)

Responsibilities:

  • Understanding of ICH, GLP, CGMP requirements, GXP regulations and current industry practices.
  • Demonstrated teamwork, initiative, and problem-solving skills
  • Ability to prioritize and work independently with minimal supervision
  • Ability to accurately determine deadlines and ask for help if needed
  • Detail oriented with solid problem solving acumen.
  • Ability to work effectively in a team environment with great organization skills.
  • Ability to independently analyze and reconcile moderate to complex issues.
  • Must have demonstrated initiative and accountability in a fast paced environment.
  • Excellent verbal and written communication and interpersonal skills.
  • Proficient with computers and word processing software (i.e., Microsoft Office products)

Education:

  • Minimum, a BS degree in life sciences, engineering or related field
  • Minimum of 5 years pharmaceutical quality assurance experience in a GMP manufacturing and supply chain environment
  • To have been involved on a device development project before as QA
  • Signed off on design development plan, completed design verification, approved DHF deliverables
  • Good understanding of FDA and EMA regulations and guidelines
  • Excellent organizational, communication, and interpersonal skills.
  • Preferred Quality Drug Substance manufacture experience
  • Knowledge of relevant government regulations and agency rules for labeling (CFR & EudraLex Volume 4, Annex 13)

Job Types: Full-time, Contract

Schedule:

  • 8 hour shift

Education:

  • Bachelor's (Preferred)

Work Location: Remote


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