No Deviation is a provider of patient-centric solutions for the pharmaceutical industry, and we are currently seeking individuals who are passionate about joining our team. Our areas of expertise include engineering consultancy, Commissioning Qualification Validation (CQV), as well as Quality, Compliance, and Regulatory services.
We strongly uphold our core values of Empathy, Integrity, and Transparency, and we strive to create a collaborative, innovative, and inclusive work environment that fosters personal growth and development.
By joining our team, you will have the opportunity to make a meaningful impact in the pharmaceutical industry while advancing your career.
Scope and Responsibilities
- Performs all MSAT functions associated with process transfer and process support. e.g. perform gap analysis / FMEA, generate process models, author / review process documentation (e.g. BRs), author / review / implement quality documents (e.g. change control, CA/PA), perform process monitoring (manufacturing data summary and analysis, data presentation), author campaign summary, perform activities for lot release (assess deviations and process changes).
- May provide guidance on process transfer and support activities of the team.
- Assess all major deviations for impact product quality.
- Take ownership of subsequent CAPA.
- Effectively work with other departments and interface with customers.
Qualifications:
- Bachelor of Science degree in Biological Sciences or Biomedical/Chemical Engineering.
- Experience in biotech industry in process development and process scale up / manufacturing.
- Experience with large-scale manufacturing support, current Good Manufacturing Practices, US / EU regulations.
- Technical understanding of upstream and downstream unit operations