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Qualified Person
2 months ago
About the Role:
We are seeking a highly skilled and experienced Qualified Person to join our Pharmaceutical Quality Assurance team at Lonza. As a Qualified Person, you will play a critical role in ensuring the quality and compliance of our pharmaceutical products.
Key Responsibilities:
- Undertake the duties of a Qualified Person as defined in the Directive 2001/83EC as amended: Directive 2017/1569 and Regulation 536/2014 during the confirmation of Drug Substance and Drug Substance intermediate
- Review the relevant required documentation associated with the manufacture and testing of Drug Substance and Drug Substance intermediates
- Support QA Leadership in the day-to-day management of the Pharmaceutical Quality System (PQS) to ensure compliant life cycle management of products and full adherence to the PQS
- Provide support and guidance on Quality matters for QA as appropriate to ensure QA drives continuous improvements and maintains fit for purpose PQS
Key Accountabilities and Duties:
- Ensure that all process/stages/actions in the manufacture, testing, and shipping adhere to the cGxPs /SOPs / Regulatory requirements and guidelines. H& S and Environmental guidelines.
- Review batch documentation, environment monitoring data, investigation reports, change request, SOP's, Qualification reports, and GMP requirements
- Review and confirm batches according to manufacture and shipment schedule ensuring all batches are in compliance with regulatory requirements
- Assess quality-related issues and provide directions to relevant departments to allow efficient resolution of issues
- Identify and make recommendations for improvements to the process within the overall continuous improvement process of the company
- Maintain eligibility to be named as a QP on the required MIA and MIA (IMP)
- Remove barriers and support continuous improvement of the quality system in line with current GMP expectations
- Manage any outcomes/deviations; ensure appropriate responses in compliance with the regulations
- Work with QA and other departments to ensure that CAPA raised as a result of the above are SMART and that CAPAs are closed by the due dates
- Represent the QP Disposition process at tier level and general meetings
- Proactively support customers' needs and provide timely responses to queries and communications
- Support regulatory Inspections and customer audits of the Operations areas and processes
Qualifications/Skills:
- At least BSc in Science or QA discipline.
- Excellent decision-making and problem-solving skills.
- Ability to meet strict deadlines.
- Ability to Streamline/lean processes
- Excellent organisational & planning skills
- Excellent knowledge and ability to interpret and translate EU and US GMP regulations and guidelines
- Excellent communication skills (verbal and written)
About Lonza:
Every day, Lonza's products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.
People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.
