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Technical Project Manager Overview

The job is for a technical project manager to oversee drug manufacturing projects, ensure process quality and regulatory compliance, and facilitate communication between manufacturing sites, quality assurance, and other departments.

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Android modded games
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2 views1 page

Technical Project Manager Overview

The job is for a technical project manager to oversee drug manufacturing projects, ensure process quality and regulatory compliance, and facilitate communication between manufacturing sites, quality assurance, and other departments.

Uploaded by

Android modded games
Copyright
© All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd

Technical Project Manager

Job responsibilities:

• Provide project management and/or technical oversight, planning, coordination, and


support to drug-product manufacturing sites for projects related to:
o API-related changes, including supplier and API-process changes
o CMO product transfers, including CMO-CMO, site-CMO and R&D-CMO
o Process Robustness and Product maintenance (e.g. due to regulatory changes)
o life cycle management, technical trouble shooting
o Process and method validation/qualification
o Overarching changes to products or materials.
• Identification, initiation, support and follow up of projects for continuous
improvement of manufacturing processes (process robustness initiative) with target
to improve efficacy (e.g. reducing off specs and cycle times, Right First-time projects)
at the manufacturing sites. Projects include:
o Stage-gate-process (R&D-to-CMO) for new products (e.g. CMC-section review)
& transfers
o Change control for drug-products (APIs, excipients, packaging),
o Contract manufacturing site technical assessments
o Qualification/validation approaches.
• Support of direct knowledge transfers involving CMOs, support of development of
global key technology platforms, technical expertise and site technology network.
• Facilitation of communication and interface for manufacturing sites to other
global/local departments such as Quality, Supply Chain Management, Regulatory
Affairs, Pharma R&D, Global Supplier Management, and CMO Organization.
• Support or lead investigation teams established to solve major quality issues
occurring with our AH pharma products.

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