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Catalent Pharma Solutions
,
Dartford, Kent
QMS Manager 12m FTC
Overview
Job Description
Position Overview: Catalent hires people with a passion to make a difference to the health of millions of people globally. Your expertise, coupled with Catalent's advanced technologies and collaboration with thousands of innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents , ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives. Interested in learning more about life at Catalent? Start here Closing date 14th June Catalent have opening for a Quality Management System Manager on a 12m Fixed Term Contract at our Dartford site. The QMS Manager will manage a Quality Management system at the site in line with cGMP's requirements and Catalent standards and ensure continuous improvements of the QMS in line with standards/trends and in an effective way. Responsibilities: Be the site leader for Quality Management Systems (QMS) - driving compliance and continuous improvement of policies and standards across the Dartford site: training, internal/supplier audit, Quality and Technical agreement management, SOP's, regulatory and compliance trends. Provide a centralised point of contact for the Dartford site on specific Quality Systems activities. This includes, but is not limited to; * Manage the QMS * 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) Provide quality data and other metrics that demonstrate the status of the QMS policies/standards and application across the Dartford site. Review and approve validation and qualification protocols and change controls on behalf of the Quality department. Review batch record documents and manage the release process when non QP release is required. Lead training programs and face to face GMP training on site. Expert in data integrity and leading site remediation plan. Expert on root cause analysis Skills & Experience: Must have extensive experience in quality roles, including experience of auditing. Proficient in electronic QMS Proficient in the use of Trackwise Thorough knowledge of EU, US and other regulations relevant to Catalent pharmaceutical operations as well as a strong working knowledge of API manufacturing. Ability to be assertive to ensure appropriate GMP and business standards are achieved Must be customer orientated. Competitive salary and benefits Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees 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. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. personal initiative. dynamic pace. meaningful work. Visit www.catalent.com/careers to explore career opportunities. 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, protected veteran status, sexual orientation or gender identity. 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, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process. Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.