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Senior Technical Manager Job
Eingestellt von Yoh
Gesuchte Skills: Support, Client
Projektbeschreibung
THE BIG PICTURE:
- Perform the following to drive closure of deviations, change controls, and CAPAs
- Perform CMO batch record review in support of lot disposition activities
- Support team as needed to drive closure of records, such as follow-up with SMEs.
WHAT YOU'LL BE DOING:
- Provide temporary Quality oversight for Client's products manufactured at a CMO Site to ensure compliance with cGMP regulations and Client's standards.
- Collaborate with site management teams, Lot Disposition, Planning, and other stakeholders to meet disposition timelines.
- Generate Trackwise reports for team to monitor status.
- Develop and generate metrics to drive on-time closure of records (ie, # of open records, # overdue, etc).
- Coordinate PQS implementation activities, Quality Agreement revision timelines, and other quality activities as needed.
- Manage communication of product complaints between internal complaint group, CMOs, and site management teams; track receipt of CMO complaint reports by due dates.
- Develop, implement and maintain a structure to facilitate communication between site management teams and enable knowledge management within team and dash; for example, a shared folder to store Quality Review Board investigation summaries and quality risk management reports.
- Perform additional activities as required.
WHAT YOU NEED TO BRING TO THE TABLE:
- Experience with GMP regulations and documentation review (five (5) years), preferable experience with aseptic processing documentation.
- Good communication skills, both verbal and written.
- Excellent prioritization, time management, and attention to detail.
BONUS POINTS! OTHERWISE KNOWN AS PREFERRED QUALIFICATIONS:
- BS in Science.
WHAT ARE YOU WAITING FOR? APPLY NOW!
RECRUITER: Salima Hakim
PHONE NUMBER: Yoh, a DayJ2W: CLINICAL
MONJOBJ2WPACNW
Ref:
SFSF: LS
Projektdetails
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Einsatzort:
South San Francisco, 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:
IT Entwicklung, Sonstiges