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Requirement of Quality Manager at Remote, Remote, USA
Email: [email protected]
From:

Jyoti Tyagi,

TEK Inspirations LLC

[email protected]

Reply to:   [email protected]

Hello,

Hope you are doing well,

Please check the below job description and let me know if you have any suitable candidate for the same:

Job Title : Quality Manager III 

Location : Remote

MOI      : Skype

Must Have Skills:  

10-12 years of experience (Experience at Consultant orDirector Level preferred) 

Pharmaceutical or Medical Device regulationsexperience 

Pharmaceutical Manufacturing Experience

  Writing, reviewing andnegotiation of Quality Agreements with Vendors

  Strong Vendor Managementexperience (role will serve as the liaison between vendors and internal stakeholders) 

Previous experience overseeing internal audits and reporting metrics 

GXPdocumentation Nice to Have: 

15 Years of Experience

 Qualification:

Minimum Education: Bachelor'sDegree/Undergraduate Degree in engineering or technical discipline

Principal Duties:

Lead the management and improvement of Sanofis mRNA CoE Inspection ReadinessProgram.

Maintain current Internal/External audit calendars and prepares and organizesaudit management activities.

Plan audit calendars, develop audit schedules and maintain audit logs.

Communicate with external vendors, schedule creation and ensure timely projectdeliverables.

Scheduling, planning, execution and documentation of internal audits ofSanofis mRNA CoE QMS.

Ensures all audit findings are closed in a timely manner with effectivecorrective action, by assisting owners on investigations and action plans.

Lead resource on inspection preparation, resolution management of audit andinspection findings and liaises with auditing groups and inspectors through allstages of the audit.

Leads the execution of the remediation responses to ensure progress byworking with key stakeholders in their timely completion of identifieddeliverables.

Lead the organization and maintenance of the Vendor Management Program, whichincludes the vendor approval and qualification process as well as maintenanceof the Approved Vendor List.

Ensures new vendor request forms are created and vendor evaluations arecompleted.

Lead resource in communication with external vendors for creation and responseto vendor questionnaires.

Write, review and negotiate Quality Agreements with Vendors.

Minimum Education: Bachelor's Degree/Undergraduate Degree in engineering ortechnical discipline.

Thanks & Regards,

Jyoti Tyagi

IT Technical Recruiter

TEK Inspirations LLC - 13573 Tabasco Cat Tr. Frisco, TX 75035

Email:   [email protected]

Contact No.: 469-842-8936

Connect with me on LINKEDIN: https://www.linkedin.com/in/jyoti-tyagi-a6350a210/

Keywords: information technology Texas
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Tue Feb 07 02:43:00 UTC 2023

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