Qualified Person
Norgine, United Kingdom
Job Description
Norgine are looking to recruit a Qualified Person to join their team based in Hengoed. As QP, your role will be to ensure both product quality and regulatory compliance requirements are met for products manufactured, packed, QC tested and/or QP released at the Hengoed site.
Responsibilities include but are not limited:
- To carry out the duties of a Qualified Person as defined in the EU guide to cGMP and to provide resource for the certification of batches for release to market in compliance with the Human medicines Regulation 2012 and EC Directives 2001/83, 2001/20 and 2003/94, EudraLex Vol 4.
- Be aware of the status of the quality and operations systems on site and propose actions to maintain in an acceptable condition.
- To release batches according to standard procedure.
- To assess deviations and act appropriately.
- Maintain an understanding of current and forthcoming legislation that impacts manufacture of pharmaceutical products.
- To maintain an understanding of current product licence requirements.
- Develop proposals for efficiency savings in the release process.
- To be a point of leadership for discussion of product quality issues in the facility, providing education, operational support, technical input and knowledge management to staff.
- To continuously review the batch certification process to ensure it remains compliant and efficient, striving for continuous improvement in security, reduction in lead times, and reduced resource needs.
- Identifies potential compliance gaps, resource constraints, adverse trending or new regulatory requirements and formulate remediation/development proposals for endorsement by site management.
- Interact with systems to ensure that quality and regulatory compliance status is identified, communicated and acted upon in a timely manner.
- Conduct cGMP compliance audits.
Experience Required
- A scientific degree is essential and suitability for immediate registration as a ‘Qualified Person’ is mandatory.
- An extensive knowledge of current GMP, GDP and GCP.
- Experience auditing in GMP/GDP/GCP/ISO environments.
- Experience with regulatory and ISO inspections.
- Knowledge of Global guidelines for the manufacture of pharmaceutical products.
- Experience of working within Quality Management Systems and knowledge of how they can add value and ensure compliance within a pharmaceutical company.
- Able to make data driven recommendation/decisions and take appropriate action.
- Ability to present effectively to groups.
- Strong influencing skills.
- A leader, quality champion and team player.
If you think you have what it takes, you must apply to be considered.
Norgine has a direct presence in 16 European countries, as well as Australia and New Zealand. We also have a strong global network of partnerships in non-Norgine markets. We are a flexible and fully integrated pharmaceutical business, with manufacturing (Hengoed, Wales and Dreux, France), third party supply networks and significant product development capabilities, in addition to our sales and marketing infrastructure. This enables us to acquire, develop and commercialise specialist and innovative products that make a real difference to the lives of patients around the world.