Qualified Person

Catalent Pharma Solutions are seeking to recruit an experienced Qualified Person (QP). 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. The Role Provide QA expertise to ensure Quality processes operate to acceptable standards. Certification of finished products prior to release for clinical study. Review and approve GMP documents where required, including deviations, batch documents and other GMP documentation. liaise with technical and other quality organisations within Catalent and their clients to investigate and generate recommended improvements for batch release. Participate in the management team investigating and performing product recalls Ensure the regulatory requirements for batch release and certification are met. To fulfil the routine duties of the QP as described in Directives 2003/94/EC, 2001/20/EC and 2001/83/EC. Continuous Improvement: To identify quality improvements and enable improvements to be implemented in a compliant and controlled manner. Ensure the timely review and approval of deviations and complaint investigations. The Candidate Qualified person in accordance with Directive 2001/20/EC., and / or Qualified person in accordance with Directive 2001/83/EC. BSc or equivalent in a relevant scientific discipline, eg Chemistry or Biology Demonstrable experience and sound knowledge of GMP regulations Competence in both written and verbal communication Good organizational skills Ability to interact with personnel at all levels from a variety of disciplines Strong follow-up skills and attention to detail Ability to be decisive regarding material/quality issues Ability to work independently Position Benefits Annual Salary Hybrid Working Pension Life Assurance 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. Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone’s safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage. 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 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. Catalent = Catalyst Talent Your talents, ideas, and passion are essential to our mission: to develop, manufacture, and supply products that help people live better, healthier lives. Join us! personal initiative. dynamic pace. meaningful work. Catalent is the perfect place to grow your career if… You enjoy the fast pace of a start-up, but want the opportunities and stability of a growing, publicly traded company (Listed on NYSE: CTLT). You want meaningful work. From cough treatments to cancer-fighting drugs, biologics, and vitamins, we help develop, launch, and supply over 200 new products each year – more than any branded drug maker in the world! You want to plant your career in a growing company. Over the last five years, Catalent has re-invested more than $2 billion back into the company and its people. You are excited about learning, collaborating, and growing alongside a global diverse team. Our team of more than 11,000 comes to work every day ready to overcome new challenges with teamwork, advanced technologies, and a passion to deliver by putting patients first. You want to make a global impact! From North America to Europe, Asia to Latin America, we have innovative science and manufacturing teams who are looking for YOU! See how our teams are making a difference, while growing their careers and fulfilling our mission by putting patients first every day here.