Project Coordinator
Company: Rangam Consultants Inc.
Location: Irvine
Posted on: May 14, 2022
Job Description:
- This position is responsible for labeling project management
and initiating labeling artwork change requests within a cross
functional environment and subject matter expert on regulatory and
commercial labeling considerations.
- The position will lead workflow coordination within labeling
management and has responsibility for key tasks within labeling
artwork projects specific to redlining and commodity code
assignment.
- Will function as subject matter expert within Labeling
Operations and liaise primarily with Regulatory Affairs, Packaging
Engineering and Manufacturing Site Planners.
- Ensure tasks are completed according to Right First-Time
principles.
- Collaborate closely with Artwork Development team in support of
labeling artwork development and proofreading. -RESPONSIBILITIES:
- Initiate labeling artwork change request/briefs and
coordination within an artwork management system to ensure on time
completion
- Complete redlining, and input tasks in the artwork management
system
- Act as primary contact for stakeholders during labeling
development to resolve any issues and provide support where needed
to ensure workflow schedule is maintained
- Manage the labeling development and implementation schedule to
meet established timelines and negotiate exceptions to planned
delivery dates
- Key liaison and subject matter expert for packaging and
labeling between labeling management team and the Client packaging
plants and Third-Party packaging plants
- Complete labeling change documents for implementing changes
into production
- Support coordination of regulatory submission required
commodity samples -QUALIFICATIONS:
- Bachelor's Degree in Business/Engineering/Regulatory Sciences
preferred. Equivalent successful industry experience (minimum 3
years) can be considered
- Labeling experience in Pharmaceutical or Biotech industry.
Minimum of 3 years combined experience from the following areas:
Quality/Regulatory, Operations, Pharmaceutical Regulations.
- Understands Regulatory, Quality and Supply Chain aspects of
labeling and impact of non-compliance.
- Demonstrate ability to work in a highly cross functional and
global environment
- Ability to motivate and influence others
- Knowledge of applicable regulations and standards affecting
Pharmaceutical products, specifically regulations and standards
affecting the Packaging and Labeling Quality System.
- Self-motivated and strong focus on details and accuracy
- Strong written and interpersonal communication skills
Keywords: Rangam Consultants Inc., Irvine , Project Coordinator, Other , Irvine, California
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