Qualified Person
3 weeks ago
Qualified Person
Their goal is to be one of the world’s most innovative, best performing and trusted healthcare companies. Their strategy is to bring differentiated, high-quality and needed healthcare products to as many people as possible, with our three global businesses, scientific and technical know-how and talented people.
We have a new opportunity for a Qualified Person to join our team at Harlow, UK. The successful person will perform the quality assurance activities and quality oversight of the GMP functions performed within Pharma R&D. As a Qualified Person, is personally accountable to conform to the legal regulatory requirements as stated in Clinical trials - Directive 2001/20/EC, Article 62(1) of Regulation (EU) No. Provide Qualified Person certification as defined in EU directive 2001/20/EC, regulation 536/2014, Article 51 of Directive 2001/83/EC and UK equivalents and perform QP release of a range of bulk and primary packed Investigational medicinal products
• Ensure a compliant operation is in place to allow for UK certification of batches of Investigational Medicinal Products and assure products meet regulatory requirements and that they conform to regulatory submissions.
• Provide QP advice and consultancy working with project teams, external collaboration partners and external sponsors to reduce regulatory risk to and ensure information and other QP assurances are obtained (as required).
• Develop and incorporate effective processes and procedures in Product Quality Pharma R&D and may contribute to business processes and procedures outside Product Quality Pharma R&D including coaching, mentoring, or training.
• Participate in routine or regulatory audits and investigations, such as Quality Investigations, customer complaints and vendor complaints and make recommendations for corrective and preventative actions, and to follow up on the implementation of those recommendations.
Science degree and extensive experience in pharmaceutical manufacturing and quality operations.
• Eligible to act as Qualified Person in the UK
• Experienced in Regulatory Inspections
• Broad knowledge of quality management
• Experience with Batch Review as a Qualified Person is mandatory for this position
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Harlow, Essex, United Kingdom Undisclosed Full timeQualified Person Duration: 8 months Their goal is to be one of the world’s most innovative, best performing and trusted healthcare companies. Their strategy is to bring differentiated, high-quality and needed healthcare products to as many people as possible, with our three global businesses, scientific and technical know-how and talented people. We...
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