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Compliance Investigator Job
Eingestellt von Yoh
Gesuchte Skills: Support, Engineering
Projektbeschreibung
THE BIG PICTURE - TOP SKILLS SHOULD YOU POSSESS:
- CAPAs
- Investigations
- Deviations
- cGMP
WHAT YOU'LL BE DOING:
- Open deviations within required timeframes
- Author investigations and support resolution of product complaints, Out Of Expectation, Out Of Specification, Out of Tolerance results
- Use process knowledge and root cause investigation tools to identify root causes of product and process deviations.
- Supports documentation of experimental plan, execution, and results to support investigations
- Ensures robustness (complete, accurate and defendable) of all critical and major investigations
- Work cross-functionally to assess and analyze deviations and investigations to determine impact
- Generation and documentation of effective corrective and preventative actions
- Ensures all CAPAs are implemented through GMP systems (eg MBR revision, training, etc.)
- Monitor and ensure effectiveness checks of CAPAs are conducted
- Provide timely updates to management on status of all GMP-related investigations
- Identifies opportunities for operational improvements for both manufacturing and deviation/investigation management
WHAT YOU NEED TO BRING TO THE TABLE:
- Degree in Engineering, Pharmaceutical Technology, Chemistry, Pharmacy or equivalent scientific degree
- Minimum three (3) years experience in GMP manufacturing role on the shop floor and/or QA/QC
- Proven process understanding (Pharma, GMP, Regulatory aspects)
- Experience in opening of deviations within required timeframe, closing of investigations within required timeframe, Effective CAPAs
- Success rate of internal audits and Health Authorities' inspections
BONUS POINTS! OTHERWISE KNOWN AS PREFERRED QUALIFICATIONS:
- Desirable MSc. or equivalent experience
OPPORTUNITY IS CALLING, APPLY NOW!
RECRUITER:Hannah Cihlar
Yoh, a DayJ2W: CLINICAL; MONJOB
TAX TERM: CON_W2J2WMIDATL
Ref:
SFSF: LS
Projektdetails
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Einsatzort:
Morris Plains, Vereinigte Staaten
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Projektbeginn:
asap
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Projektdauer:
Keine Angabe
- Vertragsart:
-
Berufserfahrung:
Keine Angabe
Geforderte Qualifikationen
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Kategorie:
Ingenieurwesen/Technik, Sonstiges