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Job Description

Responsibilities:

Lead discussions with the prospective customers in positioning Manufacturing Quality operations and processes with focus on the Digital Plant Solution.

• Building and consulting practice for full spectrum of QMS IT solutions (QMS IT strategy, Configuration, Change Management, Implementation) for Pharmaceutical and Medical Devices customers.

• Develop and Maintain relationship with target and client executives

• Lead proposal development, client presentations and project negotiations

• Lead client projects to develop use requirements, QMS IT Vendor Management, Implementation plan, Cost/Benefits analysis

• Build mutual beneficial partnership with QMS IT vendors such as Sparta/Trackwise, EtQ, Quality Document management systems etc.

• Collaborate in identifying, assessing, and selecting innovative ideas from internal and external sources based on their value proposition

• Collaborate in spreading knowledge and enhancement of the workforce capabilities.

• Drive rapid design and development of minimum viable products, supporting future business models and innovation in Manufacturing and supply chain

• Support scale up of successful ideas

Qualifications:

The candidate must have :

Excellent Understanding of Pharma Manufacturing (Chem API, Biotechnology, Formulations, Aseptic and Injectables, CRO's, CRAMS)

• Good knowledge of Med Devices quality management & assurance process

Understanding of Pharma Mfg. latest trend of technologies that drives Industry 4.0/Quality 4.0

• Experience of handling USFDA, MHRA, UDQM Inspections
• Strong experience in analytical method transfers of sites to site, RA submission support.
• Experience in Implementation of chromatography, Trackwise QMS
• Ability to demonstrate improving compliance status of Manufacturing sites and leveraging to global sites
• Strong knowledge of process validations, cleaning validations, analytical method validations, HVAC, Purified water, and Nitrogen system validations.
• Experience of Quality Control, stability studies, analytical method transfers, technology transfer.
• Experience in Supporting team for identified new organisms and validating the microbial validations using harmonized methods.
• Experience in Managed laboratories at optimum cost, improved cycle time on release.
• Expert in remediating the Mfg. site from warning letter status to no observation, management of data integrity plan.
• Experience of designing investment Vs Benefits proposals

Exposure to the latest technology trends in the Digital Manufacturing and IOT based solutions.

Should be able to lead solution architecting and strategy roadmap on Information technology and Architecture applied to business process/rules in a pharma mfg. environment.

Important points to note:

• Years of experience required for position 15+ years of industry Experience

• Location for the position Indianapolis

• Will any of these positions have any employees reporting into them? If so, please provide the employee numbers - NO