Senior Pharmaceutical Quality Assurance Specialist
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• 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
• 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
• 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
Since 2001, we are a solid pharmaceutical company, with a harmonious development in the fields we approach: research, production and distribution. Our mission is to improve people's health by offering quality products at affordable prices and our vision is to become one of the strongest and most reliable pharmaceutical manufacturers in Romania by investing in expanding and diversifying our product portfolio.
We are own one of the most modern pharmaceutical factories, complying with the rules of Good Manufacturing Practice (GMP) for the production and distribution of medicines, with top-level research laboratories, modern production lines and a strong team of medical and healthcare representatives and sales, we are among the main domestic competitors on the Romanian pharmaceutical market.
Our portfolio exceeds 100 products (prescription drugs, over-the-counter drugs - OCTs and food supplements), and our projects aim to expand the range of products annually both on the Romanian market and for the foreign market and are supported by investments focused on improving our products and services, with the main objective of consumer satisfaction and sustaining a healthy life.