Catalent Pharma Solutions QMS Manager in Dartford, United Kingdom
Catalent’s +1,500 strong, international quality team is focused on delivering nearly 7,000 products to patients in over 80 countries with the highest level of quality standards across multiple superior drug delivery and manufacturing technologies at more than 30 facilities.
Catalent require a QMS Manager at our Dartford facility. The successful candidate will manage a Quality Management system (i.e training, SOP, internal audit, technical writing of main quality documents) at the site in line with cGMP’s requirements and Catalent standards.
This is a shift-based role with the requirement to work a rotating shift pattern as follows:
6am – 2pm Mon – Fri (AM shift)
1.30pm – 10pm Mon to Thurs and 1.30pm – 7pm on Fri (PM shift)
Be the site leader for Quality management systems – driving compliance and continuous improvement of policies and standards across the Dartford site.
Provide a centralised point of contact for the Dartford site on specific Quality Systems activities. This includes, but is not limited to;
Site, Customer and Corporate KPI/Metrics
Maintenance of Master Data i.e. Item Masters (MRP & Trackwise)
Quality IT Systems Admin
Document Archiving (On/Off site)
Keep abreast of all current and future GMP and Regulatory requirements and standards in relation to Quality management systems.
Review and approve validation and qualification protocols and change controls on behalf of the Quality department.
Review and approve controlled documents on behalf of the Quality department.
Manage client’s audits as well as support Regulatory Inspection and response
Manage the document control of procedures and SOP’s and other quality records (i.e quality manual & plan, SMF when required).
Responsible to maintain the site training matrix.
Lead training programs and face to face GMP training on site.
Expert on root cause analysis
Technical Skills & Experience:
Must have extensive experience in quality roles, including experience of auditing.
Proficient in electronic QMS
Proficient in the use of Trackwise /ComplianceWire (E-training systems)
Excellent verbal and written communication
Clear thinking/logical with strong personal organization skills.
Why Work for Us:
Our Vision is to be the world’s most trusted, reliable and innovative drug development and delivery partner by upholding the highest industry standards and exceeding customer expectations, while driving strong, sustained growth for the company.
Competitive salary + Bonus + Healthcare + Dental Plan + Pension
Catalyst + Talent. Our name combines these ideas. From drug and biologic development services, to delivery technologies to supply solutions, our highly skilled and dedicated global team of over 9,500 is passionate about improving health and wellness by combining their personal expertise and advanced technologies to advance science and supply products of the highest quality to customers and patients around the world.
Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help develop some of the nearly 200 products we launch each year or help supply over 7,000 products for patients around the world. Catalent is an exciting and growing international company where our professionals work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market, for the benefit of patients globally.
Our MISSION is to develop, manufacture and supply products that help people live better, healthier lives.
OUR VALUES are at the foundation of everything we do:
Patient First: We put patients at the centre of our work to ensure the safety, reliable supply and optimal performance of our products.
Customer Dedication: We strive to exceed our customers’ expectations every day.
People: We are committed to the growth, development and engagement of our people.
Innovation: We develop and apply innovative solutions, superior technologies and continuously improved processes.
Integrity: We demonstrate respect, accountability and honesty in every interaction.
Excellence: We have a passion for excellence in everything we do.
Catalent. More products. Better treatments. Reliably supplied.™ Visit www.catalent.com/careers to explore career opportunities.
Catalent offers rewarding opportunities to further your career – join the global drug development and delivery leader! You will help develop some of the nearly 200 products we launch each year or help supply some of the over 7,000 products for patients around the world. Our highly skilled, dedicated global team of over 9,500 is passionate about improving the health of patients by combining their personal expertise with advanced technologies to advance science and supply innovative new products of the highest quality to patients globally.
Gain unparalleled experience by working on multiple products and technologies – we launch nearly 200 new products for our customers each year.
We have 20 global pharmaceutical Product Development teams on five continents, who are, at any given time, working on over 700 new products and hundreds of ongoing clinical trials.
Our products include some of the latest life-saving medicines as well as some of the most well-known consumer health brands used by families every day.
Catalent’s more than 30 global facilities on 5 continents manufacture over 70 billion doses of over 7,000 important medicines and consumer health products.
Nearly 1 in 20 doses of medicines taken around the world has been touched by the Catalent team.
We have +1,100 patents on many superior patient-preferred technologies used by all the top pharmaceutical, biologic and consumer health companies.
We established the Catalent Applied Drug Delivery Institute to drive collaboration and scientific exchange among industry professionals, academics and partners.
Many of our 1,400+ scientists are regularly published in top industry journals and present at top industry conferences to advance knowledge sharing and the development of better life-saving medicines.
Catalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected veteran status. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email along with the job number and title to Jobs@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be routed to a recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.