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Senior Project Manager | Amneal Pharmaceuticals | Ahmedabad, India
Written by MiJobz 3750210     January 11, 2014    
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Career Opportunity at Amneal Pharmaceuticals

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Contact Details

Amneal Pharmaceuticals

Services Offered

Services Offered
• We have a laser-focus on where we want our business to be and a good idea of how to get it there. Yet you'd be surprised at how open-minded Amneal is about the source of a good opportunity. After all, you don't usually find Purple Cow in the more obvious places. And we are determined to find-or create-our own.

Salary Offered

Salary Offered
Please Inquire

Qualifications & Experience Required

Qualifications & Experience
Desired Skills and Experience:
• MSC or M.Pharm in Chemistry/ MBA or equivalent combination of education.
• Experience in API synthesis or in API manufacturing company.
• Prior project management experience preferred.
• Previous technical and managerial experience in resolving API related issues.
• Sound knowledge of current regulatory requirements for API & finished dosage form and GDUFA.
• Demonstrate proficiency with ICH/cGMP guidelines, DMF requirements.
• Presentation, documentation, and interpersonal skills as well as a team-oriented approach. • Proficient computer skills in Word, Excel, PowerPoint, email and Internet.
• Basic computer skills using MS Project.
• Flexibility and the ability to handle multiple tasks to meet deadlines while delivering high quality work in a dynamic environment.

Job Description:
• A Chemist or a scientist who is well versed about the Chemistry and regulation behind the API development & filing for regulated market; to sever the position as Sr. Project Manager at Amneal Pharmaceutical in Strategic Sourcing and Supply Management Department; to lead & manage Amneal’s Global Projects from sourcing till its launch.

Core Responsibilities:
Technical Role:
• To ensure the DMF provided by vendor is in CTD format
• To ensure the DMF is as per the complete assessment check list
• To ensure the DMF complies the current ICH guidelines
• Preliminary review of the DMF for the impurities, stability section, process and specification
• To ensure vendors meets all the criteria of the GDUFA regulation & USFDA requirement of filing
• To be well-versed with all the upcoming requirements of USFDA, EDQM and other regulatory agency for filing the dossier in respective countries

Communication and Management Role:
• Material planning and resource management for the development projects
• Primary bridge between the internal team and external API vendors for the tracking of API timeline
• Facilitator between other departments within the company for the API & excipient related tasks/issues
• Driving weekly/fortnightly teleconference calls with formulation, analytical, regulatory team for project status and API updates
• Facilitator for internal team to resolve any API & excipient related technical issues with vendors
• To provide the management an overview about the plan V/s actual achieved target on each product by various analytical tools, tracking sheets, reports and by maintaining the API track record for each product
• Monthly over all reports/presentation on the progress of each project on API front to the management and R&D team
• Early risk/alert identification in the project and informing the same to the management on time for the suitable response mechanism [Mitigate, Transfer, avoid or accept]
• Vendor management in order to get the most update from them on API development, DMF filing, deficiency response and commercialization throughout the life cycle of the product
• Co-ordination with commercial purchase team to transit the project from R&D to commercial scale at the time of product launch

Leadership Role:
• An entrepreneur with a flare of driving business oriented decisions in complex situations
• A leader with a goal to achieve the target with respect to scope, time & cost along with risk mitigation, Scope management
• A system provider for the better integration of various Cross-functional teams and their alignment towards project delivery
• Proper alignment and the utilization of the team to serve the internal team on the projects
• A self- learner to keep one –self updated with the change in the industry and regulatory requirements and at the same time, the team should also be updated and trained well with all the changes

Method of Application

Is a MiJobz Profile Required to Apply?
Not strictly, but a MiJobz profile is a significant advantage
Can Candidates Apply by Phone?
Swap Start/End

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