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
- 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 email@example.com to discuss further today!