Bonafi is a fast-growing compliance tech start-up company in the pharmaceutical industry. Our mission is to support companies manage the end-to-end qualification cycle of their customers and suppliers through automation and digitalization.
At Bonafi, we value diversity, integrity, and respect within the workplace. We believe that diverse perspectives and backgrounds foster innovation and drive growth.
Overview of the job’s responsibilities:
Bonafi is seeking an experienced Quality Assurance Associate who will contribute to strengthening our Quality Management System and company. The Quality Assurance Associate at Bonafi will work hand-in-hand with our Development Operations Teams, QA Testers, and other stakeholders to deliver a timely, high-quality compliant SAAS product.
Who will love this job?
We believe that this job is for someone who
- will take the chance and make an individual impact through autonomy and responsibility
- is a self-motivated, multi-tasker, proven team player within cross-functional teams
- thrives in a start-up environment and can contribute to original ideas
- is good at rolling up their sleeves to achieve results in a start-up environment
- enjoys Critical thinking/evaluation of process problems skills
- who has strong work ethic and the ability to work independently
The ideal candidate should enjoy improving how things are done, as well as making sure they get done
What you’ll contribute to and be responsible for:
- Collaboration with the Head of Quality Assurance and other Department Managers to enhance internal compliance, through continuous improvements
- Supporting the setup and shaping of our Quality Management Systems
- Preparing for our ISO9001-2015 Certification and maintaining compliance within the ISO9001 framework
- Writing and/or review of documentation that supports GxP activities for accuracy, completeness, compliance, and user-friendliness, e.g., SOPs, instructions, validation documentation
- Leading, coordinating, or performing deviation investigations
- Management / Implementation of Corrective and Preventive Measures, Change Controls, and Software Life Cycle Controls.
- Providing training to other parts of the business on the Quality Management Systems
- Participating in internal and external audits and implementing any resulting recommendations/actions
- Reviewing and evaluating customer complaints; supporting root cause determination and risk assessments as necessary
- Consideration of General Data Protection Regulation (GDPR) in documentation
- To undertake any further duties, from time to time as may be reasonably required
- Successful, timely completion of goals and objectives that strengthen the Organisation.
- Progress reporting against deadlines
What we look for in a candidate:
- Understanding of relevant quality regulations, such as ISO 9001 and GxP e.g., Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP)
- At least two years of experience in Quality Assurance within a regulated industry, particularly in pharmaceutical/life science industries.
- Qualification, preferably in a related field.
- Proficiency with Microsoft Office, including Word, Excel, and PowerPoint, is necessary for performing essential job functions and analysing data.
- Strong written, oral, and presentation skills in English, as well as the ability to work well in a team and possess critical thinking skills
- Knowledge of GAMP – Good Automation Management Systems
- Experience in working with quality compliance software and/or Computer Software Validation
Posted 06 January 2023