5.0 - 9.0 years

0 Lacs

maharashtra

On-site

As a Qualified Person within the Quality department at Piramal Critical Care (PCC) in Haarlem, Netherlands, your primary responsibility will be to certify batches of Medicinal Products before release for sale. This includes ensuring compliance with EU-GMP regulations, relevant EU-directives such as 2001/83/EC and 2011/62/EU, Dutch National Legislations, and overseeing that public service obligations are met. Collaborating with key personnel like heads of production, quality control, quality assurance, and supply chain, you will be responsible for supervising the company's activities to ensure continuous compliance with legal requirements. It is essential for the Qualified Person to be regularly present at the facilities where the operations take place. Your role as a Qualified Person involves certifying and confirming that each finished medicinal product batch complies with GMP, Marketing Authorization, and applicable EU and Dutch National laws. You will also be responsible for evaluating deviations, participating in investigations, recording certifications, approving subcontracted activities, and ensuring self-inspections and audits are conducted regularly. Additionally, you will play a crucial role in approving quality agreements, change controls, process validations, and participating in risk assessments, audits, and inspections. It will be your responsibility to keep appropriate records of delegated duties, decide on the final disposition of products, handle customer complaints, and ensure GMP aspects are implemented and maintained in the quality management system. To qualify for this role, you should be eligible to act as a Qualified Person under EC/2001/83 Directive, have experience in certifying sterile and solid unit dose products, and possess some background in quality assurance for narcotic products. Fluency in Dutch and English at a minimum C1-level is required. At Piramal Critical Care (PCC), we are committed to inclusive growth and ethical practices. We offer equal employment opportunities based on merit, ensuring that all applicants and employees receive fair treatment in personnel matters. Join our team dedicated to delivering critical care solutions globally and contributing to sustainable and profitable growth for all stakeholders.,

Posted 2 weeks ago

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