The Company
Bigfinite Inc. is the outcome of years of expertise and the commitment to guide and lead biotech and pharma manufacturing into the future leveraging our AI/ML technology. With headquarters based in San Francisco and development in Barcelona, we are working with the latest technologies and top worldwide companies as partners (like Amazon). We've developed a Serverless SaaS platform, based on IoT, big data, artificial intelligence, and pharma 4.0 technologies, offering an intuitive way to gain meaningful operational intelligence by enabling real-time visibility, faster root cause analysis, and predictive insights for AI-augmented decision making in a GxP compliant manner with end-to-end data integrity. Bigfinite’s technology platform can enable pharma/biotech customers to accelerate their manufacturing process while improving quality and compliance.
Our Vision, Mission, and Values
We are looking for new members of our team who already live by our shared values and are inspired by our company vision. Vision: helping pharma and biotech industries improve the efficiency and quality of their operations through the use of Artificial Intelligence technologies ensuring total traceability through simple IT solutions. Our mission is to improve manufacturing processes to positively impact society. We are guided by our values: innovation, efficiency, collaboration, interdisciplinary, joy, respect, and commitment.
The Position
QA Engineer
Location
Position located in Barcelona
Responsibilities
- Reporting to QA Manager. A senior profile with a Life Science or Computing Engineering studies or similar experience.
- Revise and create Standard Operating Procedures (SOP’s), Work Instructions (WI's) and other controlled documents in collaboration with process owners and subject matter experts for CSV.
- Guide testing and compliance efforts to ensure regulatory, quality, and safety priorities are adequately addressed
- Work with computer system owner(s) to ensure the implementation of change control activities are in accordance with company procedures and compliance requirements
- Effectively facilitate meetings to discuss and complete risk assessments required by 21 CFR Part 11 and Data Integrity compliance guidelines
- Maintain oversight of the user, functional, and system requirements to meet the IQ/OQ/PQ testing objectives while managing a traceability matrix to verify all testing is conducted and properly documented
- Ensure that the organization’s Integrated Management System conforms to the customer, internal, ISO guidelines and regulatory/legal requirements
- Assist with the planning and execution of internal audits, preparation of plans and audit reports
- Support on-site audits and implement corrective actions
- Work with different IT teams in order to optimize processes, correct them and ensure continuous improvement of productsProvide advice and support to all departments on Quality Assurance
- Develop, define the terminology used in documents to ensure easily understood by all audiences
- Assist the QA Manager to implement, maintain and improve the Integrated Management System (ISO 9001 - ISO 27001)
- Assist internal audits and third-party audits (internal and external).
- Quality assurance activities related to: Software Development Life Cycle (SDLC) from requirements to release, Business processes, Quality training for employees and third parties
- Define and improve bigfinite platform compliance: GxP requirements definition, Define platform qualification: IQ-OQ- PQ testing
Qualifications
Quality systems (ISO 9001 - Pharmaceutical Quality Systems)
Pharmaceutical regulations: manufacturing (GMP) and computerized systems (21 CFR Part 11 - EuGMP Annex 11)
GAMP 5 guidelines on Computer System Validation (CSV)
Basic knowledge of Industry 4.0 concepts and principles
IT cloud tools (Amazon Web Services, Atlassian ecosystem: Confluence, Jira, Bitbucket and Google G Suite)
Risk management
Agile software development
Proficient in spoken and written English
Position Home- Based in Barcelona
Skills
Have experience working on Quality in IT business
Technical writing: procedures, policies, work instructions
Ability to read and interpret regulations, guidance documents, technical manuals, forms and instruction guides
Critical eye to be quality-oriented
Possessing an agile mindset, fast to adapt to constant changes and feeling comfortable with it
Naturally questioning everything
Excellent communication skills, both within and outside the team
Have experience working on a dynamic product that is ever-changing and evolving rapidly
Strong analytical and creative problem-solving skills
Ability to take smart risks and champion new ideas
Team player, collaborative, innovative, get things done mind
Ability to understand business requirements and translate them into technical requirements
Show initiative in setting and meeting goals within an environment of managed change
What we offer:
Immediate start
Competitive salary in the sector, according to your experience and skills
A collaborative work environment with a young, dynamic international team
Full time and permanent contract with a flexible schedule
Language training courses
Private medical and dental insurance
Stock options
Internal training and certifications
Career plan and scheduled salary reviews
Team building activities
