QA Specialist

Location Switzerland
Discipline: Biotechnology, Pharmaceutical
Job type: Temporary/Freelance
Contact name: Aliyana Darwesh

Contact email: a.darwesh@panda-int.com
Job ref: 19165
Published: 18 days ago

JOB ALERT!
One of our industry-leading Biotech Clients require support from a QA Specialist for ongoing high-level projects in Switzerland.  This is an opportunity to work with a fast-paced organisation and world-class technology on an 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

Location: Switzerland.

Duration: 18 months (high chance to an extension)

Interested? Get in touch by sending your CV and phone number to a.darwesh@panda-int.com or call on +31202044502!