- Experience Level
- Experienced (non-manager)
BAP Pharma are Global Leaders in Clinical Trails supply, specialising in comparator sourcing and secondary packaging. Founded in 2011, BAP Pharma, is an incredible story of growth and success, steadily expanding its operations, with a presence in the UK, USA and Germany.
We are a team of professionals who have a passion for delivering on our promises to each other and our customers. We are driven to create exceptional value and an unrivalled service. Our culture is one of openness, honesty, and respect. Our goal is to become a Global Leader in the Clinical Trails Supply Industry.
We are now looking for people with a passion for great customer service and doing the right thing, to help us take the business forward. Our people are our greatest asset, our future is exciting, come join us!
BAP have an amazing opportunity for a Quality Officer to join our busy and growing team.
This role will ensure that BAP Pharma GmbH are compliant to both GMP and GDP requirements and follow the guidance stipulated by the German Health Authority. In addition, manage BAP Pharma GmbH to be fully compliant to the requirements of ISO9001:2015.
- Ensure compliance to GMP and GDP regulations.
- Support the maintenance of QMS - CAPAs, deviations, change controls and complaints.
- Support the RP with ensuring BAP Pharma adhere to the Falsified Medicines Directive.
- Support the Goods-in and Goods-out processes.
- Writing, reviewing and approving SOPs within the Electronic Quality Management System.
- Support the RP during product recall, complaint investigation, deviation and CAPA implementations.
- Support the supplier and customer verification programme/development.
- Support the RP during self-inspections and external audits.
- Oversee the warehouse operations and ensure that temperature conditions are maintained, and seasonal mapping and calibration activities are conducted in a timely manner.
- Provide support during client and German Health Authority inspections.
- Provide support during internal staff training on GxP elements.
- To ensure that the provisions of the WDA(H) and MIA(IMP) are met at all times.
- To ensure that BAP Pharma documentation are managed in accordance with Good Documentation Practices and Data Integrity.
- Support the RP during validation activities (preparation of documentation & execution of testing).
- To manage the Quality Key Performance Indicators.
- Support the RP during Quality Management Review Meetings.
- Knowledge of The Human Medicines Regulations (i.e. AMG, AMWHV, AM-HandelsV).
- Knowledge of Eudralex, The Rules Governing Medicinal Products in the European Union, Volume 4 Good Manufacturing Practice, Medicinal Products for Human and Veterinary Use.
- Good Understanding of the GMP and GDP Regulations.
- Good understanding of the WDA(H) and MIA(IMP) obligations.
- Understanding of Directive 2001/83/EC as amended, of the Community Code relating to medicinal products for human use.
- Understanding of, The New Guidelines for Good Distribution Practice of medicinal products for human use (2013/C 343/01).
- Educated to a degree level within a life science subject.
This role reports to the Director of Operations & Responsible Person. Overtime may be required from time to time to meet project deadlines. You must have the ability to work under own initiative and as part of a team. We have a diverse range of employees with different cultures and background s and are committed to diversity and inclusion
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