Check all associated application documentation thoroughly before clicking on the apply button at the bottom of this description.
Location: Hatfield, Hertfordshire - 5x per week
Industry: Pharmaceuticals
The Opportunity:
Our client is an established international pharmaceutical organisation with a growing UK and European presence. They are seeking a highly experienced, UK-registered Qualified Person (QP) to take responsibility for QP batch certification and lead the UK Quality Management System.
This is a senior and highly accountable position, responsible for ensuring the quality, safety and regulatory compliance of medicinal products entering the UK market.
Working closely with UK senior leadership and international Quality, Regulatory, Operations and Supply Chain teams, the successful candidate will play an important role in maintaining compliance, supporting new product launches and ensuring continuity of pharmaceutical supply.
Key Responsibilities:QP Batch Certification & Release
- Fulfil the statutory responsibilities of a Qualified Person under the Human Medicines Regulations 2012.
- Review and certify imported batches of finished medicinal products in accordance with GMP, Marketing Authorisations and UK regulatory requirements.
- Oversee batch certification and final market release for products manufactured outside the UK.
- Ensure appropriate analytical, microbiological and physical testing has been completed prior to release.
- Oversee Analytical Method Transfers between international manufacturing/QC teams and UK or European testing laboratories.
- Review and approve Out-of-Specification results, deviations, investigations and CAPAs.
- Act as RP/RPi for relevant UK/EU activities where required.
Quality Management System & GDP
- Own, maintain and continuously improve the UK Quality Management System.
- Ensure continued compliance with GMP, GDP and applicable MHRA requirements.
- Lead the development and review of SOPs, Change Controls, Deviations and CAPAs.
- Maintain the QMS in line with evolving UK pharmaceutical regulations.
- Conduct and oversee audits of external manufacturing organisations, laboratories, warehouses, logistics providers and other suppliers. xwwtmva
- Maintain appropriate Quality Technical Agreements with external partners.
- Lead quality complaint and product recall
Please click on the apply button to read the full job description
Qualified Person (QP) & QMS Lead in Ellenbrook employer: Zenopa
As a leading player in the ruminant animal health sector, our company offers an exceptional work environment that fosters collaboration and innovation. Employees benefit from a supportive culture that prioritises professional growth, with ample opportunities for training and development tailored to enhance your skills in the veterinary and agricultural fields. Located in the vibrant Central and East England region, we provide a unique chance to engage with diverse stakeholders while making a meaningful impact on the industry.
