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Hiring For GXP Auditor, Onsite at Remote, Remote, USA
Email: [email protected]
Title:- Quality

Gxp Auditor

Durham, NC onsite

Start date: mid-June-1 year contract

Minimum of 5 years of experience within

Pharmaceutical / Biotech / Medical Device industry

NO H1B

Lead Quality/
GxP Auditor Responsibilities:

Identify, analyze, and determine solutions regarding capability gaps

Partner with the business to define what a qualified RTP team member looks like based on their job responsibilities then design
an appropriate curriculum

Create, revise, and implement training and related documents, ensuring they are well written, executable, and compliant with applicable
policies/procedures

Facilitate the review of documents and training materials to ensure compliance and learning requirements are met

Ensure that training solutions are aligned to global strategy where appropriate by proactively connecting with the Global L&D organization

Ensure that current training courses/interventions are effective and if not, identify an alternative and implement

Proactively identify areas where capability challenges exist and design interventions on how to reduce those issues

Define ongoing ownership and maintenance plan for L&D interventions

Monitor learning budget for projects within assigned business area/function as applicable

Create initial project scope documents, appropriately leveraging learning services suppliers for outsourced work to achieve business
objectives

Create, review and oversee execution of implementation plan(s), ensuring effective coordination with personnel who create and revise
business area/function SOPs and other documents

Monitor and communicate program/portfolio status to key business partners

Anticipate and resolve project/program issues, escalating as appropriate

Oversee portfolio of projects to ensure on-time, on-budget creation of deliverables that meet quality standards, follow instructional
design principles, are approved by appropriate personnel, and meet needs of business (including translations and any Corporate Initiative requirements)

Drive quality standards through review of project documents, design, deliverables, final learning content and evaluation data

Think strategically about the best way to train our team members not just what has been done, but the best way to get them effectively
trained and able to use their knowledge quickly

Benchmark cross functionally within Lilly as appropriate, seeking sharing and replication opportunities

Establish strong relationship with suppliers and Lilly supplier management contacts to align on portfolio of projects and services
and ensure seamless quality of deliverables

Conduct usability testing as required

Share business metrics, interpretations, and solutions with Supervisor, business partners/process team

Participate regularly in area/function project and process teams.

Understand RTP functions deeply, including business goals, job titles and descriptions, key duties, and responsibilities

Monitor RTP team members satisfaction of learning programs and use that feedback to improve our programs

Consult across the assigned business area/function and the Lilly learning community to ensure training plans align with business
plan, strategic direction, and compliance and ethics

Influence your RTP team leaders to think about the most efficient and effective way to deliver training interventions that are
meaningful, useful, and relevant to their roles

Manage suppliers working on L&D related projects to ensure delivery and performance mirrors or exceeds our agreements; ensure that
the deliverables meet the needs of our site team members

Requirements

B.S./B.A. in scientific discipline as a minimum

Minimum 3 years of

GxP auditing experience in related industry

Minimum of 5 years of experience within

Pharmaceutical / Biotech / Medical Device industry

Experience working in a

GxP (regulated) environment.

Experience in technical writing

Demonstrated program/project management skills

Experience with learning & development business processes

Demonstrated ability to establish strong business relationships

Demonstrated ability in communication, conflict resolution, and judgment and managing complexity

Working knowledge of business area/function

Experienced in Vendor management

Ability and willingness to challenge business partners regarding ways to use learning interventions to most effectively meet business
requirements

Ability to work independently and in a team environment.

Strong start-up mindset think deliver execute review cycle

Strategic operator think of where we need to go, but also the tactical ways to get there

Thanks & Regards

Manish Kumar

Technical Recruiter

Ext:427 DID : 
469-914-9242 

Email: [email protected]

Linkedin:

linkedin.com/in/manish-chaudhary-jaat-21b9011a3 

ANVETA, Inc

Address: 1333 Corporate Drive, Suite #108 Irving, TX 75038, USA

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Keywords: information technology golang North Carolina Texas
Hiring For GXP Auditor, Onsite
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Tue May 07 20:07:00 UTC 2024

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