Pharmaceutical Manufacturing Operations Workstream Lead
Found in: beBee S US - 2 weeks ago
Seeking a Pharmaceutical Manufacturing Operations Workstream Lead to support the supply chain/quality team
ResponsibilitiesÂ
⢠Assess and review current practices, advising on appropriate strategies to correct compliance gaps through intermediation controls and/or sustainable corrective/preventive actions.Â
⢠Working with regulatory affairs to understand, interpret on agreed CMC submission strategies/commitments for approved products.Â
⢠Building best practices, skills, and capability throughout the site organization, with the focus in the Operations, Engineering, and MS&T (Manufacturing, Science and Technology) functions.Â
⢠Apply pharmaceutical operational and quality knowledge to highlight inter-process, systems and capability relationships and related activities that require improvement.Â
⢠Working with Senior Management, conduct compliance risk assessments, trend analysis, provide and communicate recommendations for compliant business activities.Â
⢠Prepare and present project update reports to senior management as required.Â
Requirements
⢠+8 years of experience in the Pharmaceutical Industry
⢠Proven delivery of large to medium scale CMC and Consent Decree projects involving manufacturing, quality, supply chain and regulatory affairs in support of commercial products.Â
⢠Previous experiences working with FDA and participating in regulatory agency inspections.Â
⢠Extensive experience in quality, manufacturing, or MS&T departments of a commercial pharmaceutical manufacturing company.
⢠Technical Experience in Validation, GMP/GLP Compliance, Pharmaceutical Engineering, Quality Assurance & Control, Regulatory Affairs, and Manufacturing Operations.Â
⢠Experience in Quality Management Systems, Quality Assurance and Compliance would be beneficial.
⢠Desired experiences in project management, change management, quality systems, quality assurance, validation, and manufacturing operations.
If you are interested, please contact madison.simon@cpl.com
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