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Subject Matter Experts - Acceptance Activities

Eingestellt von Berry Technical

Gesuchte Skills: Sap, Client

Projektbeschreibung

Subject Matter Expert -Acceptance Activities
CHF Negotiable
Solothurn, Switzerland
6 month contract

Our client is seeking an experienced Subject Matter Expert to join their team on site in Solothurn.

Responsibilities
- With oversight from the Core Team Leads, determine and report on the state of compliance of the quality system versus regulatory standards (ISO, FDA, etc.).
- Audit sites' inspection Plan to the standards and report out on findings (both current state and retrospectively).
- Make recommendations to achieve compliance where shortfalls are found.
- Provide Audit reports as directed.
- Perform analyze and define Inspection Plan as necessary.
- Generate Inspection Plan as necessary.
- Background on statistics.
- Background on validation.
- Be willing and able to travel domestically to other Legacy Synthes EU sites as required.
- Thorough understanding of GMP and GCP (Good Clinical Practices) guidelines.
- Generate DCRs/DCOs that these achieve the regulatory and the business requests.
- Fluent German spoken and written English is an advantage
- Be able to work with various databases to extract and report out required information (Excel, Access, Q-DAS SAP etc.)
- Good communication skill.
- Know and follow the guidelines regarding the code of conduct, ethics and compliance programs and other relevant regulations at all times.
- Excellent organizational skills, readiness to take on responsibility, reliable, proactive & self-driven, very good communicational skills, customer oriented.
- Team player.
- Travel required form site to site.
- Be able to manage effectively multiple priorities and tasks.

Experience:
- Minimum of 4 years quality planning
- Compliance experience in the medical device.
- Prior experience in medical device/pharmaceutical remediation preferred.
- Familiarity and interaction experience with regulatory auditing bodies preferred.
- Documented training in FDA QSR, ISO 13485/9001 required.

Proficient in the use of spreadsheet software (Access/Excel etc.)

Competencies:
* Non technical/soft skills (Differentiate must-haves vs nice-to-haves)
Team player
Independent autonomous
Work well under pressure

Experience:
Experience Medical Device, FDA - must
Acceptance activities - consulting, control plan
Mechanical experience

Projektdetails

  • Einsatzort:

    Solothurn, Schweiz

  • Projektbeginn:

    asap

  • Projektdauer:

    6 months

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

  • Kategorie:

    IT Entwicklung, SAP Entwicklung

  • Skills:

    sap, client

Berry Technical