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Senior Quality Specialist

Eingestellt von Quanta Consultancy Services

Gesuchte Skills: Support, Engineering

Projektbeschreibung

The Sr. specialist will be reporting to the Director, within the department that supports all Quality Systems Compliance activities to ensure compliance with all documents as well as applicable regulations and specifications are in line.

PRIMARY ACTIVITIES INCLUDE, BUT ARE NOT LIMITED TO:

- Ensure that Quality Bulletin is deployed through all SMLM sites, ensure its effectiveness, support site variances and ability of site to maintain level of compliance Confirm closure of activities according to plan Support sites on implementation ofrelevant Quality Alerts and Quality Bulletins.
- Partner with the Global SO and SSO for chapters to proactively identify initiatives and enhancements. Serve in the role of administrator to ensure a continuous improvement mindset for the AHQM documents. Support Tier III roll out to SM LM sites and relative training in my Learning.
- Assist in various programs across sites as identified by the AH SMLM, including, but not limited to:
- Quality and Compliance Excellence(QCE), in particular,
- Support Global SO and SSO for periodic review of the system.
- Inspection Readiness Masterplan and review with Site prior to planned inspection, and responses.
- Support sites for Divisional audit and responses.
- Support and contribute to internal compliance forums to identify any emerging trends for continuous improvement in the SM/LM region related to Quality Systems requirements

These activities include:

- Driving improvements from significant investigations and/or current compliance trends within both SM and LM regions.
- Support QSC as expert for SM/LM in review of AHQM policies and procedures linked to MMMD policies and guidelines, and providing perspective of QSC to sites.
- Prepare AHQM policies and procedures once required in the area of Quality Management together to the Director, AH Quality systems Compliance.
- Partner with the SMLM sites, to ensure the overall compliance posture for the AH SM/LM is resilient and sustained.

REQUIRED EXPERIENCE:

- Bachelors degree in an appropriate scientific or engineering field of study is required.
- Preferred fields of study include Biology, Biochemistry, and Microbiology.
- An MBA or other business degree in addition to the required science or engineering education, is a plus.
- At least eight(8) years of work experience in a pharmaceutical biologics and/or vaccine manufacturing environment or a strongly related, similarly regulated field.
- Strong understanding of cGMPs, FDA, EU, USDA and EPA regulatory standards.
- Strong compliance mind set.
- Strong lean mindset with MPs Kata capabilities.
- Ability to work within a Matrix organisation to align on expectations and resolutions.

Projektdetails

  • Einsatzort:

    Niederlande

  • Projektbeginn:

    asap

  • Projektdauer:

    12 months + Extension

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

Quanta Consultancy Services