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Principal Quality Engineer
Eingestellt von Yoh
Gesuchte Skills: Support, Engineer
Projektbeschreibung
JOB RESPONSIBILITIES:
- Support his/her counterpart in the Quality Systems function for management of inspectors from diverse regulatory agencies (eg EMA, MHRA, RP Darmstadt, ANVISA, FDA, TGA, etc.)
- Compile/provide metrics in support of activities related to Quality System activities (including but not limited to Deviations, Investigations, CAPA, Change Control, Effectiveness,Review, PPR, QMR, regulatory commitment closure) on a periodic and ad-hoc basis
- Interpret data and vet data with Biostatistician (statistical analysis) to review significance of identified trends
- Visually display data as requested by management Write and revise SOPs and Quality Documents
- Implement Corporate Standards and Policies
- Facilitate and coordinate compliance activities with the Site Quality Council and QSRT regarding industry trends and corporate initiatives
- Facilitate, coordinate and publish the Site Risk Profile Report ensuring all follow up activities are tracked and monitored
- Special projects as assigned by manager, specifically, assist in developing the requirements for a site document archive management program
JOB QUALIFICATIONS:
- Bachelor's Degree and nine (9) years of experience in Quality/Regulatory in a GMP environment OR Master's Degree and seven (7) years of experience in Quality/Regulatory in a GMP environment Knowledge in external agency regulations
- Experience with Trackwise or equivalent system Proficient in Microsoft Office Ability to learn technical knowledge (pertinent to the areas of oversight) quickly
- Strong written and verbal communication skill
DISCOVER ALL THAT'S POSSIBLE WITH YOH. APPLY NOW.
RECRUITER: Natane Peslis
Yoh is a professional staffing provider with over 70 years of experience in the short- and long-term staffing services industry.
Yoh, a DayJ2W: ENG
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SFSF: LS
Projektdetails
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Einsatzort:
Framingham, Vereinigte Staaten
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Projektbeginn:
asap
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Projektdauer:
Keine Angabe
- Vertragsart:
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Berufserfahrung:
Keine Angabe
Geforderte Qualifikationen
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Kategorie:
Ingenieurwesen/Technik, Sonstiges