Sr QA Specialist

Location Switzerland
Discipline: Biotechnology
Job type: Temporary/Freelance
Contact name: Ivan De Marcos Ospino

Contact email: i.ospino@panda-int.com
Job ref: 18942
Published: 17 days ago

Currently working with a Biotech Client in Switzerland who are in need of support from a Sr QA Specialist for ongoing high-level projects.  This is an opportunity to work with a fast-paced organisation with cutting edge-technology, for a JUICY 18 month contract! Interview + offer will take place this week and next, so get in touch asap if interested.


Duties And Responsibilities

  • Supports the deviation process. Ensure (and lead if necessary) that the initial quality assessment is completed in a timely manner according to requirements, support investigators and assess the criticality, review and approve the deviations and related CAPA.
  • Support the CAPA process by approving all the CAPA plan, and the completed action. Ensure review and approval of effectiveness check.
  • Supports the change control process. Performs action plan evaluation and coordinates change control progress within assigned areas of responsibility.
  • Reviews and approves as QA representative qualification and validation activities documents (protocols, reports…).
  • Perform batch record review and prepare batch release documentation on support of the Quality release team.
  • Contributes to risk assessments, e.g. related to quality issues or projects like new product introduction.
  • Represents QA within department and cross-functional project teams according to assignments.
  • Acts as backup for colleagues within QA Operations team.
  • Contributes to SOP/WP revision. Can take the ownership of processes and document revision
  • Supports health authorities and internal inspections in different roles (SME, coordinator, etc…)
  • Participate to Quality KPI establishment and monitoring
     

Competences

  • At least 5 years of experience in a pharmaceutical company or other related industry.
  • BS or MSc in Science or related field.
  • Good understanding of cGMPs and FDA regulatory requirements.
  • Good understanding of solid oral dosage form manufacturing processes is preferred.
  • Thorough understanding of cGMP requirements
  • Works independently on routine tasks, makes proposals and facilitate decision when escalation is needed.
  • Excellent Investigational and problem-solving skills.

Start Date: ASAP

Duration: 18 months 9extension possible)

Interested? Contact me by sending CV to i.ospino@panda-int.com to discuss further today!