Quality Officer

3 months ago

Edinburgh, United Kingdom Cambrex Full time

: Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance, drug product, and analytical services across the entire drug lifecycle. With over 40 years of experience and a growing team of over 2,200 experts servicing global clients from North America and European sites, Cambrex is a trusted partner in branded and generic markets for API and dosage form development and manufacturing. At Cambrex, our people set us apart. We’re committed to attracting, nurturing, and retaining a passionate and talented team of valued experts in our fast-paced and growing company. We offer an exceptional benefits package including medical, dental, vision, Life, LTD, generous vacation in your first year, sick time, and retirement savings Known for our scientific and manufacturing excellence, as well as our strong customer focus, we offer a range of career opportunities across our global network of locations. Together with our customers, we aim to improve the quality of life for patients around the world. Overview:
The role will be based at **CAMBREX EDINBURGH, **the site is a world leading contract research organisation offering solid form screening, crystallisation development and analytical services to the pharmaceutical industry. **CAMBREX EDINBURGH** operates a Quality Management System in accordance with the requirements of BS EN ISO 9001:2015, EU GMP’s, the requirements of its customers and in accordance with applicable regulatory requirements.

**Responsibilities**:

- Reporting to a Quality Manager you will be a leader in supporting the Quality Management System (QMS). This includes, as example, tracking/administration duties, review and approval of deviations, investigations, change management, CAPA and SOP’s
- Ensure all activities were performed as per approved SOPs/methods/protocols and comply with specifications by critically evaluating the reported data and results for accuracy and compliance.
- Assist with internal, external, and regulatory audits.
- Will promote and assist/ lead on the continual improvement of the QMS.
- Advise and guide the operations team in QMS requirements -Create an effective relationship with Quality team, colleagues, and clients.
- Perform assigned tasks carefully and on schedule.
- Assist the Quality Manager in collating and reporting of quality related Key Performance Indicator’s
- Other duties as assigned.

Qualifications:

- BSc in chemistry or in related field (or relevant experience).
- +2years Quality experience working with GMP in the pharmaceutical or bio/technology industries.
- Knowledge and experience with techniques such as HPLC, GC, FT-IR, UV/Vis, Karl Fischer, Total Particle Counters and Chromotography data systems is advantageous.
- Experience in validation, release testing and/or stability environment would be desirable as would ISO 9001:2015 QMS knowledge.
- Cambrex is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status._
- #LI-SK1_

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