AddressBCI offers personal and professional development opportunities and a supportive environment where performance is rewarded, and success celebrated. We believe in appointing the right candidate for each position while ensuring that recruitment and selection is conducted in a way that is transparent, consistent and effective. We are a professional, committed and creative team. Working with us you will get the opportunity to show lots of initiative and take on responsibilities at an early stage. As a growing organisation we will continue to innovate and evolve, which means roles will change and develop. We are committed to the continuous learning and development of all staff to enable people to develop individual skills and realise their full potential. We aim to engage all staff with a challenging and exciting learning culture and encourage openness, discussion and feedback so we can develop and continuously improve what we do. We offer a variety of in-house training, as well as the opportunity for staff to develop long-term career plans. We understand the need for a good work-life balance. We therefore support and operate several flexible working schemes including job-share and flexible working hours where applicable. Among the clients we work with, we hold an immaculate track record and as a BCI consultant you will have the unique opportunity to tangibly prove to several companies how valuable you can be to their operation. You can join BCI under permanent or contract positions and choose the locations you want to work. In return we offer an attractive remuneration based on your qualifications, expertise & experience.
- Main duties would be to ensure that all Quality and Compliance requirements are met for Customers, Suppliers, Internal Departments and Regulating Agencies in accordance with applicable EU regulations.
- Management of various quality parameters, such as; Complaints, Deviations & CAPA, Audits, Quality Metrics, SOPs, Change control, Specifications, Manufacturing Documentation Approval and Training and Batch Certifications.
- To provide QP GMP declarations including on site audits if required.
- Review study and lot specific documentation necessary to facilitate QP Release. Use technical knowledge to assess the criticality of any issues.
- Liaising with the Regulatory Authorities.
- Provide support for resolution of technical problems involving existing global supply products
- Actively encourage input/development of QMS, Site Quality/EHS Councils and Continuous process improvement.
- Experience in auditing suppliers, consultants, API facilities, and drug product manufacturing or testing sites.
- Should be eligible Qualified Person with experience in undertaking the routine duties of a Qualified Person and in a Quality related role within the pharmaceutical industry.Background and skills
- Relevant University Qualification in the chosen area of expertise
- Minimum of 2 years pharmaceutical experience or associated manufacturing industry experience.
- Knowledge in sterile, solid and liquid dosage forms.
- Broad knowledge of pharmaceutical manufacturing processes.
- Good inter-personal skills and presentation skills.
- Location: UK or Europe
- Fluent in English or any other European languages
Associate / Consulting Opportunities
BCI is always looking to recruit more talent to its growing team of experts to create a dynamic environment full of exciting opportunities and where you can finally make a difference. If you would like to explore exciting career opportunities and interested to work with some of the best and brightest and provide complex consulting and training services to leading companies around the world, then contact our team.
info@bci-gmp.com
