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November 21 2018

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Job Opportunity: Serialization Manager:Fastnet ? The Talent Group

Job description:

Serialization Manager

Fastnet - The Talent Group


   » Cork
   » Negotiable
   » Permanent full-time
   » Updated 18/10/2018
   » Claire McGuckin this job is expired SaveSave Apply Now

Job detail


Permanent Opportunity with Leading Cork located Biopharma client
 

Responsibilities
   » Lead and support the identification, interpretation of both emerging and changing global serialization regulations, industry standards (and subsequently determining the impacts of these changes to related systems and business processes.
   » Interact with external organizations implementing serialization/ track and trace solutions to understand their road map, changes to the road map and assess impact to company systems, interfaces to CMOs and processes
   » Assist in the roll-out of a corporate track and trace solution through sustainable and robust processes
   » Lead the design and implementation of effective business processes for the implementation of a global serialization and track and trace program
   » Leverage strong business analysis, technology and data management practice to help design future state business models and processes
   » The scope of the analysis and related work will be across all sites, functions and CMO's that support the companies serialization related business processes (current or future). Perform capcapability assessments and identify gaps to either justify:
   » A new capital project or
   » A change order to an existing in-flight capital project or
   » Incorporation of the change via operational support
   » Assigning the activity as appropriate to the serialization portfolio
   » Manage assigned global cross-functional strategies and activities connected with the implementation and management of these serialization activities for all commercial products across all manufacturing sites including contract manufacturing organizations.
   » Assess the impact for any new product launches or packaging / labeling changes, identify and manage completion of tasks to address any gaps
   » Provides leadership abilities, direction and management of a team, to support execution of the Supply Chain strategy.
   » Provides oversight, guidance and management of personnel working on assigned projects and operational support processes.
   » Creates and maintains a positive working environment to ensure high productivity, employee engagement and performance.
   » Exercises independent judgment in developing methods, techniques, and evaluation criteria for obtaining results.
   » Reviews, and/or implements changes to controlled documents as needed. May author sections of regulatory documents.

Knowledge & Skills
   » Possesses an in-depth knowledge of Global Serialization requirements, Track & Trace models, and connected technical systems / equipment & processes to support these needs.
   » Able to develop solutions to a wide variety of complex problems, which require the regular use of ingenuity and innovation.
   » Solid working knowledge and skills of significant US, EU and international pharmaceutical cGMPs / regulations
Fastnet has a strict confidentiality policy - please be assured that your details will never be mailed to any third party without your consent.
Fastnet - The Talent Group
'Not Just Placers.........Partners'
The Life Science Specialists
Ref: JO-1810-63921_1539876818
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Fastnet - The Talent Group


   »  


   » Eastgate Village, Eastgate Business Park, Little Island, Cork
   » 021 4509200
   » jobs@fastnettalent.com
   » http://www.fastnettalentgroup.com



Skills:

Job Category: Customer Service [ View All Customer Service Jobs ]
Language requirements:
Employment type:
Salary: Unspecified
Degree: Unspecified
Experience (year): Unspecified
Job Location: Cork
Company Type Employer
Post Date: 10/18/2018 / Viewed 77 times
Contact Information
Company: Fastnet ? The Talent Group
Contact Email: jobs@fastnettalent.com


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