Catalent, Bathgate are looking for a Permanent Qualified Person (QP) with Sterile and Biological Product experience.
As the QP for our Clinical Supply Services site in Bathgate your role will see you act as Qualified Person for the Bathgate facility and provide a full QP service to Clinical Supplies Services, and their clients.
Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.
The Role
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Provide QA expertise to ensure Quality processes operate to acceptable standards.
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Certification of finished products prior to release for clinical study.
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Review and approve GMP documents where required, including deviations, batch documents and other GMP documentation.
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liaise with technical and other quality organisations within Catalent and their clients to investigate and generate recommended improvements for batch release.
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Participate in the management team investigating and performing product recalls
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Ensure the regulatory requirements for batch release and certification are met.
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To fulfil the routine duties of the QP as described in Directives SI 2012/1916 and SI 2004/1031.
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Continuous Improvement: To identify quality improvements and enable improvements to be implemented in a compliant and controlled manner.
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Ensure the timely review and approval of deviations and complaint investigations.
The Candidate
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Sterile and Biological Product experience
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Experience of Biotech Products
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ATMP product experience preferred but not essential
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Qualified person in accordance with Directive SI 2012/1916 and/ or SI 2004/1031.
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BSc or equivalent in a relevant scientific discipline, eg Chemistry or Biology
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Demonstrable experience and sound knowledge of GMP regulations
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Competence in both written and verbal communication
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Ability to interact with personnel at all levels from a variety of disciplines
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Strong follow-up skills and attention to detail
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Ability to be decisive regarding material/quality issues
Position Benefits
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Annual Salary
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Hybrid Working
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Pension
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Life Assurance
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Healthcare Insurance
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 Catalent Careers to explore career opportunities.
Catalent is an Equal Opportunity Employer and does not discriminate based on any characteristic protected by local law.
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 [email protected]. 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.
