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THE POSITION

The purpose of this role:

• To act as a Qualified Person named on the site Manufacturing Authorisation as defined in EU Directive 2001/82/EC Article 52

• To fulfill the statutory legal duties and responsibilities of a Qualified Person in accordance with all applicable EU and UK regulations, Directives and Professional Code of Practice

• To provide expert support to maintain compliance to GxP requirements.

• To deputise for the site Quality Manager during their absence

• To operate an effective and streamlined process to certify and release to market batches of product and antigens meeting compliance and GMP standards.

• To improve quality, facilitate quality management and contribute to the development of a right first time, quality culture.

TASKS & RESPONSIBILITIES

• Perform the duties expected of a QP as laid down in legislation under UK, EU GMP and the Qualified Person Code of Practice.

• Ensure that the necessary checks and tests have been performed such that each batch of product released from the site complies with UK/EU GMP and BI Animal Health Quality standards, and the relevant Regulatory Authorisation for the intended market.

• Perform the release of antigens and vaccines made on the Pirbright site to ensure timely release of product.

• Maintain Continuing Professional Development (CPD) as required by the QP Code of Practice.

• Keeping up to date with legislation updates

• Maintaining product and process knowledge for products produced on the Pirbright site.

• Support regulatory and customer inspections, acting as a Subject Matter Expert for batch certification.

• Support the site Quality Manager with quality issues, site projects and initiatives as required.

• Investigate, manage and actively resolve quality investigations as needed, e.g. through deviations, CAPA, change control in conjunction with appropriate persons within Pirbright and in other FMD manufacturing sites and suppliers to minise impact on antigens and vaccine availability and sales.

• To support supplier qualification activities by providing guidance and expertise to the process.

• To perform internal and external supplier audits as required by the site and the corporate quality team

• Support with Key Site Projects

• Utilization of skills in Quality review and approval of aspects related to process and product critical projects

• Mentorship and Development of skills in Quality aspects of employee duities.

• Support the Product Quality team in continuous improvement of Quality Record Review

• When applicable, support future development of Qualified Persons training programs

• Cross-functional area development and training in growth of understanding and mindset related to Quality documentation review, in particular Batch Record related documentation

REQUIREMENTS

• Scientific degree, ideally life science / pharmacy / veterinary medicine / chemistry / pharmaceutical chemistry and technology / biology.

• Preferably EU Qualified Person or eligible for nomination as an EU/UK Qualified Person under the Permanent Provisions of EU Directive 2001/82/EC

• In-depth experience of production of veterinary/human medicines within a Quality Assurance environment

• Good knowledge of scientific principles covering physical-chemical, microbiological and immunological assays and European Pharmacopoeia standards

• Excellent working knowledge of EU GMP and Quality Assurance requirements

• Leadership, strength of proposal and conviction

• Capable to innovate and to challenge the current processes, and to adapt to an ever changing environment

• Good IT skills (MS Office, TrackWise, SAP)

WHY THIS IS A GREAT PLACE TO WORK

Boehringer Ingelheim has been recognised as a Top Employer in the UK. Being certified as a Top Employer confirms our dedication to a better world of work, delivered through excellent HR policies and people practices. To learn more visit: https://www.boehringer-ingelheim.co.uk/careers/uk-careers/why-great-place-work

All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.