Senior Pharmaceutical Quality Assurance Specialist

Din 2001, suntem o companie farmaceutică solidă, cu o dezvoltare armonioasă în domeniile pe care le abordăm: cercetare, producţie şi distribuţie. Misiunea noastră este să îmbunătățim sănătatea oamenilor oferind produse de calitate la prețuri accesibile, iar viziunea noastră este să devenim unul dintre cei mai puternici și de încredere producători de produse farmaceutice din România prin investiții în direcția extinderii și diversificării portofoliului de produse.

Deţinem una dintre cele mai moderne fabrici de produse farmaceutice, respectând regulile privind Bună Practică de Fabricaţie (GMP) pentru producţia şi distribuţia medicamentelor, cu laboratoare de cercetare de cel mai înalt nivel, linii de producţie moderne şi o puternică echipa de reprezentanţi medicali şi de vânzări, ne numărăm printre principalii competitori autohtoni de pe piaţa farmaceutică din România.

• 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

• 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

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