Quality Officer

3 weeks ago


Edinburgh, United Kingdom Cambrex Corp. Full time

Company Information

**You Matter to Cambrex.**

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 more than 40 years of experience and a growing team of over 2,400 professionals servicing global clients, Cambrex is a trusted partner in branded and generic markets for API and dosage form development and manufacturing.

**Your Work Matters.**

At Cambrex, we strive to build a culture where all colleagues have the opportunity to:

- engage in work that matters to our customers and the patients they serve
- learn new skills and enjoy new experiences in an engaging and safe environment
- strengthen connections with coworkers and the community

We’re committed to attracting and nurturing a passionate team of valued professionals in our fast-paced and growing company. We offer a competitive benefits package that includes healthcare, life insurance, planning for retirement, and more

**Your Future Matters.**

Job 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/Skills
- Be well organised and able to plan one’s own work effectively based around business/quality priority needs.
- Possess good problem-solving and effective time management skills.
- Demonstrated ability to think critically and pragmatically and to focus on details of execution.
- An enthusiastic team player with strong interpersonal skills to communicate with members within the quality and operations departments.

Education, Experience & Licensing Requirements
- 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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