QA Specialist
vor 1 Woche
To enhance the Quality Assurance team of a pharmaceutical company, we are seeking a Quality Assurance Specialist with strong skills in validation activities.
We are offering a fixed-term full-time contract until December 2024.
Position Summary
The selected individual will join the Quality Assurance Team to help establish and uphold the Company's Quality System and ensure the consistent reliability of the manufacturing process. Primarily focused on QA procedures, the role involves overseeing equipment and installation qualification, process validation, and other related tasks.
Essential Tasks and Responsibilities
- Creation and issuance of qualification documents, final reports, and GMP-related paperwork
- Execution of equipment and process qualifications, as well as cleaning validations
- Monitoring KPIs and data analysis for continuous quality system enhancement
- Managing Deviation and Change Control processes
- Conducting quality investigations and implementing corrective actions
- Developing Standard Operating Procedures (SOP) and GMP documentation
- Contributing to innovative industrial projects
- Participating in inspections and audits
- Drafting validation protocols and reports
- Creating staff training plans and organizing training activities
- Collaborating with production and maintenance teams on qualification activities planning
More specifically, the role entails:
- Planning and coordinating validation activities
- Establishing relationships with external validation service providers
- Providing training to employees involved in validation activities
- Participating in the development of Validation Master Plans and Project Plans
- Executing planned validation tasks
- Ensuring new equipment installations comply with documentation
- Bachelor's/Master's degree in technical scientific fields (Chemistry, Pharmacy, Engineering, or similar)
- Minimum 5 years of experience in pharmaceutical production or quality assurance
- Expertise in injectable anesthetics and terminally sterilized products is a plus
- Strong understanding of pharmaceutical manufacturing and GMP procedures is advantageous
- Proficiency in Italian and English, French knowledge is beneficial
- Excellent communication, teamwork, and organizational skills
- Ability to drive continuous improvement
If you find this opportunity aligns with your profile and skills, we welcome your application.
