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Quality Assurance Specialist

Eingestellt von Berkley IT

Gesuchte Skills: Engineering, Sap

Projektbeschreibung

BERKLEY ENGINEERING ARE CURRENTLY SEEKING EXPERIENCED QUALITY ASSURANCE SPECIALISTS FOR 6-12 MONTH CONTRACTS WITH OUR PHARMACEUTICAL MANUFACTURING CLIENT IN DUBLIN

KEY RESPONSIBILITIES:

* Collaborate with cross functional team to deliver project deliverables on time, on budget, and with Quality requirements being met
* Review and edit project documentation ensuring that Quality requirements are met
* Provide QA approval on finalized project documentation
* Contribute to equipment and process risk assessments
* Provide QA oversight for equipment qualification and commissioning activities including but not limited to factory acceptance testing and site acceptance testing
* Evaluate validation protocol content and execution
* Is a champion for safe working practices and safety initiatives within their area

BASIC QUALIFICATIONS

* University degree. Engineering or Science related discipline preferred
* Significant experience (10yrs +) working in the pharmaceutical or biotechnology industry

PREFERRED QUALIFICATIONS
* Excellent written and verbal communication skills
* Experience working with dynamic cross-functional teams and influencing decisions
* Experience working in aseptic operations, protein formulation, syringe filling
* Experience working with isolator and e-beam technology
* Experience with ASTM 2500 approach to equipment commissioning and qualification
* Understanding/experience with Trackwise, Change Control Management System, EDMQ and SAP
* Knowledge of applicable Regulatory requirements
* Experience with Regulatory inspections
* Operational Excellence experience

Berkley Engineering is a specialist recruitment consultancy which recruits pharmaceutical, medical device and clinical professionals throughout Ireland, Asia, UK and Australia

WE ARE ACTING AS AN EMPLOYMENT BUSINESS.

Projektdetails

  • Einsatzort:

    Dublin, Irland

  • Projektbeginn:

    asap

  • Projektdauer:

    6 - 12 months

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

  • Kategorie:

    SAP Entwicklung, Ingenieurwesen/Technik

  • Skills:

    engineering, sap

Berkley IT

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