I am looking for candidates for the below positions. Let me know if you have
Position:- Developer (Job Id:- 893863)
Location:- Los Angeles, CA
Duration:- 13 Months
* Software development from design definition through integration.
* Design documentation, coding, code integration.
* Candidates will be working on the next generation of medical product.
* Participates in Design and Code Reviews, Specifies, Designs, and Debugs,
and Verifies Medical Applications Software, Participates in
Software Requirements Specifications inspections.
* DOORS is a must, Embedded software engineer.
* C language expert.
* 10 years experience with successful development of embedded software
applications with excellent communication skills.
* Medical System design experience, Thread-X operating system experience are
* Assembler, C, Windows XP and Undergraduate Degree.
* C#, MS Windows, CE, MS Project, and Graduate Degree.
Position:- Hyperion Essbase
Location:- San Francisco, CA
Duration:- 2 Months + (extension if they like the work of the person)
* ASO cube
* Excellent MDX development skills, optimize calculations
* Update and modifying 2 existing Essbase apps ( convert from BSO to ASO ,
add a dimension)
Position:- Global Manufacturing Compliance (GMC) Consultant / CMC Regulatory
Location:- Peapack, NJ
Duration:- 12 Months +
* Face to Face interview required.
* Pharmaceutical Experience is required
* Masters Degree in Computer Science or related discipline is required
* Bachelors Degree in Chemistry, Pharmacy, Biology, Biotechnology, Drug
Regulatory Affairs or other scientific discipline required.
* Masters or Ph.D. preferred.
* At least 5 years of broad based, manufacturing related regulatory and/or
quality experience with demonstrated project management and
* Successful candidates should have experience or working knowledge of
change control practices and/or dossier preparation for manufacture of
human pharmaceutical, biological and/or animal health products in global
* Qualified candidates must possess excellent communication skills (both
written and verbal) with strong technical and regulatory writing ability.
* Proven experience in multi-tasking and prioritizing projects.
* Demonstrated negotiation skills involving complex technical issues and
* Process and detail oriented with the ability to follow complex processes
and prepare large complex documents.
* Strong global knowledge in post-approval Chemistry, Manufacturing and
Controls (CMC) change regulations and in the content and structure
of the CMC section of a Marketing Authorization (e.g. NDA, MAA, IRD,
JNDA, DMF, CTD, ANDA, NADA, etc.).
* Candidate must have a thorough understanding of regulatory change
management requirements, possess a strong working knowledge of FDA
regulations and other global authorities' regulatory requirements,
demonstrated leader behaviors.
* Ability to participate as GMC representative on cross-functional project
and co-development teams, and effectively work with multiple
disciplines and personalities.
* Develop CMC regulatory post-approval filing strategies for global
* Manage CMC regulatory changes and develop global filing strategy for human
or animal pharmaceuticals or biologicals manufactured at
Pfizer Manufacturing facilities and contract manufacturers.
* Work with manufacturing sites and Center functions to facilitate the
resolution of questions and/or issues throughout the change management
* Write scientific justification based on applicable regulatory guidelines
and assembles variation package for manufacturing changes with
regulatory impact including updated dossier sections.
* Prepare responses to health authority queries and requests for CMC
information as appropriate, in accordance with Pfizer policies, practices
* Prepare and archive variations/supplements, renewals or annual reports in
electronic document systems.
* Maintain fluency in existing and emerging global CMC regulations.
* Provide CMC support to global market affiliates for license renewals and
annual reports, line extensions and territory extensions.
* Ensure that all CMC regulatory documents are prepared accurately,
completely, on-time and submission ready (format/content).
* May manage a portfolio of several products to prepare/maintain CMC
sections of Marketing Authorization Applications.
Thanks & Regards,
Senior Sales Manager I Econosoft, Inc I
Tel: (408) 228-0242 X 853
Toll Free : 1-800-566-4604 X 853
efax: (408) 324-1729 / 775-227-6817
Yahoo IM:- satwinder15
Email: [EMAIL PROTECTED]
Anuj Kumar | Regional Manager | Ext 364 |
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