- Participate in Quality Management team and be responsible for management of both the QC Microbiology and Analytical teams in delivering requirements within the company.
- Lead and develop the Quality Control team to ensure delivery of goals and achieve appropriate standards of work.
- Ensure GMP compliance with UK, EU, and US regulations is maintained in all quality control laboratories.
- Ensure all incoming materials, in-process materials and final products are tested and released to GMP standards.
- Manage in-house and outsourced GMP testing and oversee the collation of all laboratory documentation and certification necessary for batch release and stability testing.
- Ensure all microbiological and environmental monitoring testing is performed to GMP standards and supports the site contamination control strategy with respect to facilities, personnel, and process simulations.
- Develop a culture of ongoing quality improvement, ensuring that all staff understand the significance of the quality management system and its implications for patients, products, customers, and reputation.
- Actively participate in management processes to ensure decisions can be made on informed advice on issues of Quality Control.
- Experience working in this area (pharmaceutical, commercial sterile manufacturing, stem cell research) or similar field.
- Leadership capabilities and experience – great communication and motivational skills
- Working knowledge of Good Manufacturing Practice (GMP) and Quality Control principles.
- Proven in successfully delivering reports and presentations in various settings, including regulatory and customer engagements.
- Proficiency in Microsoft Office and electronic quality management systems.
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Senior Quality Manager - Edinburgh, United Kingdom - Kleboe Jardine Ltd
Description
My client is a successful global contract manufacturing organization, specializing in cell and gene therapies. They are currently looking to hire an experienced Quality Control Senior Manager for their Edinburgh location.
Check all associated application documentation thoroughly before clicking on the apply button at the bottom of this description.
This is a fantastic opportunity to join a rapidly growing company that is changing lives, giving you the skills and valuable experience to develop further and take the next step in your career.
Collaborative, dedicated and talented people are the backbone of the culture in this company, working to make life-changing products utilising ground-breaking science.
This client offers a competitive salary for this position accompanies by an excellent benefits package including 31 days annual leave + 4 public holidays (increasing with tenure), Group Life cover, Private Healthcare, an excellent company pension scheme as well as other benefits.
Job Responsibilities:
A relevant post-graduate degree or equivalent professional qualification in a Life Sciences or related subject.