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Senior Technical Manager Job

Eingestellt von Yoh

Gesuchte Skills: Support, Client

Projektbeschreibung

SENIOR TECHNICAL MANAGER needed for a contract opportunity with Yoh's client located in South San Francisco, CA.

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

  • Einsatzort:

    South San Francisco, Vereinigte Staaten

  • Projektbeginn:

    asap

  • Projektdauer:

    Keine Angabe

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

Yoh