Senior Pharmaceutical Quality Assurance Specialist

Employer: LAROPHARM
Domain:
  • Chemistry - Petrochemistry
  • Pharmacy - Health
  • Production
  • Job type: full-time
    Job level: peste 5 years of experience
    Location:
  • BUCHAREST
  • Ilfov
  • Updated at: 18.05.2021
    Short company description

    Înfiinţată în 2001, Laropharm este o companie farmaceutică solidă, cu o dezvoltare armonioasă în domeniile pe care le abordează: cercetare, producţie şi distribuţie.

    Laropharm deţine una dintre cele mai moderne fabrici de produse farmaceutice, respectând regulile privind Buna Practică de Fabricaţie (GMP) pentru producţia şi distribuţia medicamentelor.

    Requirements

    • 5+ years of QA experience
    • 3 + years of experience working with GMP in a pharmaceutical, medical device, or biologic environment
    • Bachelor’s, or higher, degree in a scientific discipline, preferable pharmacy, biology or chemistry
    • Strong interpersonal and attention to detail skills
    • Excellent writing/communication skills
    • English – advanced level

    Responsibilities

    • Participate in the implementation and improvement of the Quality System and Integrated Management in the company according to the Guide of Good Manufacturing Practice for medicines for human use (GMP), and the ISO standards;
    • Perform internal and external audits as assigned.
    • Perform review and approval of OOS, deviations, nonconformance, and investigation as required.
    • Ensure systems are in compliance with current SOPs.
    • Assist investigations and resolve potential product quality issues to improve efficiency.
    • Assist with writing, revising, and approving standard operating procedures.
    • Review and approve SOP, protocols and reports as necessary.
    • Coordinate and/or conduct GMP training.
    • Oversee revision, development and tracking of controlled documents
    • Collaborate with clients, QA team and other departments to assist in the revision, issuance of the documents
    • Manage databases used for tracking of GMP documentation
    • Review documents for accuracy, completeness, and compliance
    • Process and distribute controlled documents such as SMPs, SOPs material specification using internal document control system
    • Elaborate process and cleaning validation protocols and coordinate validation activities
    • Perform various risk assessments
    • Elaborate quality agreements

    Other info

    We offer:
    • Motivational salary package
    • Private Medical Insurance
    • Meal tickets
    • A dynamic work environment with a culture that is open, innovative and performance-orientated
    • Working in an environment with experienced people, with career improvement opportunities