CI&T seeks a Senior Quality Assurance professional to develop test automation for financial clients. Engage in full software development lifecycle within a collaborative environment.
About the role
- Quality Assurance Officer in a global health tech company ensuring compliance with GMP and GDP standards. Collaborating with cross-functional teams to maintain quality and information security management systems.
Responsibilities
- Prepare product and batch release documentation and support batch disposition
- Lead internal audits and support external vendor and regulatory audits
- Manage deviations, complaints, temperature excursions, CAPAs and Change Controls
- Maintain our electronic QMS and draft procedures, templates and training materials
- Deliver cGxP training and manage training records
- Prepare PQRs, annual updates and quality reports
- Support supplier qualification, customer approval, and vendor performance monitoring
- Contribute to qualification, validation and periodic reviews of GxP computerized systems
Requirements
- Bachelor's degree in a relevant field, ideally (bio)pharmaceutical
- At least 4 years of pharmaceutical QA experience
- Strong knowledge of EU GMP, GDP and related legislation
- Experience with QMS systems, internal audits and batch review
- Skilled in root cause analysis, CAPA and Quality Risk Management
- Excellent attention to detail and strong communication skills
- Professional English proficiency
- Nice to have: external audit experience, FMEA, experience in RA, PV, MA or Supply Chain, and system qualification experience.
Benefits
- Impactful work that helps patients gain access to potentially lifesaving treatments.
- International work environment, scale-up energy, and a flat organizational structure that encourages creativity and accountability.
- Competitive salary, annual performance bonus, and an Employee Stock Option Plan.
- Health insurance benefits through Cigna.
- 401K where we match 100% of employee contributions up to the first 3% of pay and 50% of employee contributions to the next 2% of pay.
- Great career development opportunities in a fast-growing company.
- Learning and development budget alongside internal knowledge-sharing sessions.
- Remote working model. We also have an office in Brooklyn in where you can work with colleagues.
- Policies to support working parents.
- Unlimited access to professional guidance by certified psychologists via OpenUp
- An annual ‘myTomorrowland’, which is a 2-day company-wide celebration!
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