- June 27, 2023
- Open Positions
QA Specialist
Our client is Pharmaplast – a company that specializes in manufacturing advanced wound care dressings, retail tapes, bandages, cosmetics and all their raw materials. They have a customer base of 400, in 85 countries worldwide.
For their newest location in Katunsi, Bulgaria, we are looking for a:
QA Specialist
About the role:
The QA Specialist will be actively involved in helping to prepare international product registrations, ensuring regulatory
compliance with product formulation, labels and literature and will be actively involved in the execution of Quality
Management System duties.
Job Responsibilities:
Regulatory affairs:
• Creating and maintenance of registration documentation.
• Providing regulatory expertise for medical devices.
• Anticipating and resolve key regulatory problems of global medical devices documentation.
• Coordinating and/or conducting the preparation of new medical devices applications, coordinate and drive all types of regulatory procedures.
• Creation and maintenance of relevant regulatory documentation for medical devices.
• Assessing of regulatory documentation related to manufacturing and control, safety and efficacy of medical devices.
• Conducting internal audits.
Quality Assurance:
• Developing, leading and driving all QA aspects of Pharmaplast’s projects.
• Ensure appropriate quality issue management processes are established.
• Reviewing the data analysis and final reports for studies.
• Establishing and managing the tracking system for document control.
• Conducting internal audits
Qualifications:
– Academic Level: Fresh Graduates with Bachelor’s Degree in Science, Pharmaceuticals
– Experience: Fresh Graduates or up to 2 years of experience in QA or RA in a similar industry.
– Fluent English.
– Arabic language will be considered an advantage.
– Must be customer oriented and work well with varied personalities inside and outside of the company.
– Ability to read, write and handle basic math problems.
– Ability to manage projects.
– Strong written and oral communication skills.
– Analytical skills.
– Strong knowledge of MS Excel, Word and power point.
If you are interested, please, send your CV with a recent photo.
Your personal information will be used only for the purpose of the recruitment process and will be treated with confidentiality and respect. Confidentiality is guaranteed and protected by law.
Horizons is a leading recruitment company specializing in expert and middle management positions with 18 years of experience in the Bulgarian market. Our team consists of business-oriented consultants with industrial specialization, a professional understanding of the business trends and a pro-active approach towards recruiting and hiring through different methodologies and innovations.
Horizons owns license No 2118 from 27.09.2016.