QA officer

Deadline:
01/10/2018
Centre / Institution:
Bigfinite Inc
Bioinformatics expertise:
Biomedical Informatics
Keywords:
ISO, Quality Assurance, pharmaceutical regulations

Job description

big finite is the outcome of years of expertise and the commitment to guide and lead Biotech and Pharma Manufacturing into the future.


Based in San Francisco and Barcelona, we are working with the latest technologies and top worldwide companies as partners (like Amazon). We develop and sales our product big engine, a SaaS platform based on IoT, Big Data, Artificial Intelligence and Cloud in order to optimize pharmaceutical and biotech manufacturing processes. Moving on the acquisition of large volumes of data, registration, visualization and generation of knowledge in a simple, regulated and traceable way.

 

What are we looking for:

  • Degree in Computer Science or engineering (Electronics, IT, Physics, Life Sciences)
  • ISO9001 knowledge
  • Experience in Quality Assurance and writing SOPs
  • ITIL, GAMP5 and pharmaceutical regulations knowledge would be a bonus
  • 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 skill, both within and outside the team
  • English speaking, reading and writing proficiency

 

Some of your responsibilities will be:

  • Assist the QA Manager with the maintenance of ISO 9001 QMS (SOPs and WIs)
  • Ensure that the organisation's Quality Management System conforms to customer, internal, ISO 9001 and regulatory/legal requirements
  • Monitor, measure and review internal processes
  • Assist with the planning and execution of internal audits, preparation of plans and audit reports
  • Suport on-site audits and implement corrective actions
  • Work with different IT teams in order to optimize processes, correct them and ensure continuous improvement of products. Provide advice and support to all departments on QA
  • Responsible for document management system
  • Develop, define terminology used in documents to ensure easily understood by all audiences
  • Participation in audits received from customers and Authorities
  • Report to the Total Quality Manager.

Contract duration and other benefits

What we can offer:

  • Economic support for the internship.
  • Immediate start.
  • An excellent work environment with a young, dynamic collaborative team.
  • The possibility to join a young American company with great expectations and huge potential to grow.

Required information and contact

Ana Cimadevilla

HR Manager

ana.cimadevilla@bigfinite.com