Industry - Pharma / Biotech / Clinical Research

Category - Operations

Skills - Quality, Operations, Manufacturing

Job Type - Permanent

Job Description - The Plant Quality Manager is responsible for leading the quality function within the manufacturing plant to ensure all aspects of product quality, safety, reliability and ongoing regulatory compliance (sterile environment) are achieved in line with company objectives.

Client Details : 

A Global Leader in sterile medication production (injectible) with a strong portfolio of molecules.

Job Description : 

- Be an active member of the Plant senior management team and ensure product quality, safety, reliability and compliance related goals are established and implemented.

- Be accountable for driving a sustainable quality improvement culture.

- Manage the day to day operation of the various departments and sections within the quality functions and their interaction with other departments within the Plant.

- Ensure the ongoing compliance with the company Quality System and local GMP requirements and manage interactions with all external regulatory bodies, agencies and customers to represent the company products and processes.

- Implement processes & procedures to ensure continued improvement of product quality, safety, yield, reliability and quality system compliance.

Profile : 

- The candidate is required to have a minimum of 20 year's operational experience Quality in a manufacturing environment producing sterile pharmaceuticals in compliance with EU GMP / FDA regulations. Experience in a 'sterile fill' environment and processes would be a distinct advantage.

- Technical qualification to meet the requirements to act as a Qualified Person as defined in the EU GMP's.

- Ability to manage/supervise a large diverse team of technical personnel & Strong analytical and problem-solving skills.

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