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Catalent
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Egerton, Bolton, Greater Manchester
Quality Manager & QP
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Job Type: Full-time |
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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 Catalent Pharma Solutions have an exciting opportunity for an experienced Qualified Person (QP) to join our team of pharmaceutical professionals working in our Clinical Trial and Commercial Supply facility in Bolton, UK. The Role Your role will have a particular focus on non-EU sterile manufacturing and Biological Product manufacturing facilities You will review and certify batch assembly in accordance with regulatory, internal and client requirements including the maintenance of a log relating to batch release. Act as direct Quality representative for key customer accounts, ensuring customer requirements are defined, met and responded to in a timely and efficient manner. Generate or assist in the generation, review or approval of Standard Operating Procedures, Corporate Policy Statements and other defined critical documentation. Act as Quality contact with other functions, including Production, Print room and Project Management. Promote current Good Manufacturing Practice through training and guidance, ensuring compliance with industry and regulatory standards and client requirements whilst providing expert quality guidance and support where necessary. Assist in the conduct of customer and regulatory audits and the resolution of any audit deficiencies. Audit vendor and client facilities to ensure regulatory, client and internal company requirements are met. Preparation and regular review of Standard Operating Procedures Ensure the implementation and enforcement of relevant standard operating procedures within the Quality function and across site. The Candidate Will be an Eligible QP Specialisation within Sterile and Biologics preferred Experience working with all levels in an organisation with the ability to influence internal and external stakeholders. Excellent written and communication skills, including experience of report writing and managing multiple client projects at any one time Strong organizational and decision-making skills Good attention to detail with strong follow-up abilities Specialisation within Sterile and Biologics preferred Our 7 standard leadership competencies Leads with Integrity and Respect Delivers Results Demonstrates Business Acumen Fosters Collaboration and Teamwork Champions Change Engages and Inspires Coaches and Develops Position Benefits 31.5 days holiday (inc 8 public holidays) Bonus Car Allowance Pension Life cover Bupa Healthcare 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. C atalent 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 DisabilityAccommodationscatalent.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.