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Deviation Specialist/Technical Writer Job
Eingestellt von Yoh
Gesuchte Skills: Client, Support
Projektbeschreibung
THE BIG PICTURE - TOP SKILLS YOU SHOULD POSSESS:
- Trackwise QA database or database equivalent
- GMP environment is required
- Quality Assurance (QA) systems
WHAT YOU'LL BE DOING:
- Performs a wide variety of Technical Documentation and Investigation activities to ensure that the Clinical Manufacturing Unit (CMU) meets its deliverable targets.
- Ensures that such related activities are compliant with applicable GMP requirements, and client procedures and quality standards.
- Applies knowledge of Good Manufacturing Practices (GMP) on a daily basis.
- Conducts deviation management related to manufacturing activities
- Authors and revises Standard Operating Procedures SOPs as needed
- Authors and revises Manufacturing/work instructions (MIs, WIs)
- Collaborates with line units to author/draft batch manufacturing reports (BPRs) and other supporting documentation
- Reviews data audits and report reviews as required
- Supports review of Development (PHAD) protocols
- Participates in the disposition of batches (eg batch record review)
- Provides documentation support to other projects as assigned
- Initiates deviation in a Trackwise QA database or equivalent
- Conducts investigations to determine root cause using industry tools (eg fishbone analysis)
- Ensures that Corrective and Preventative Actions (CAPAs) are implemented
WHAT YOU NEED TO BRING TO THE TABLE:
- Three (3) + years of technical writing experience, preferably in a manufacturing environment
- Experience in pharmaceutical industry working in a GMP environment is required
- Experience with writing and leading product manufacturing investigations
- Experience using Trackwise QA database or database equivalent
- Experience with Quality Assurance (QA) systems
- Strong oral and written communication skills are required
- Must have excellent interpersonal skills
- Computer literacy (MS Word, Excel)
BONUS POINTS! OTHERWISE KNOWN AS PREFERRED QUALIFICATIONS:
- Bachelors degree in a scientific discipline is recommended or AA with technical background
RECRUITER: Mary Nguyen
Yoh, a DayJ2W: SCIENTIFIC; MONJOB
TAX TERM: CON_W2J2WPACNW
Ref:
SFSF: LS
Projektdetails
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Einsatzort:
San Carlos, 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:
IT Entwicklung, Sonstiges