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Quality Specialist, IT Systems/CSV

  • Salary Type: Per Annum
  • Salary: £32,772


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

The Quality Specialist for IT Systems and Computer System Validation (CSV) is a member of the Central Quality team and is responsible for supporting the infrastructure and processes for Good Manufacturing Practice (GMP) /Regulatory compliance within Catalent Pharma Solutions. This position focuses on the full system life cycle and supporting processes for global laboratory, manufacturing, packaging, quality and regulatory affairs systems across Catalent. The new hire will report to the Quality Manager, IT Systems / CSV who is based in Kansas City, Missouri site.
The primary responsibility for the Quality Specialist for IT Systems and CSV is providing Quality oversight, guidance and support to global teams and sites to facilitate compliance with current regulatory requirements, Catalent policies, applicable GxP and data integrity. This role requires the development of good working relationships with global, site, supplier and key customer quality functions.
This position works closely with the project teams, suppliers, site quality and IT teams serving as an expert quality and compliance resource, bringing forth opportunities for the implementation of new world-class systems and leveraging existing systems to help support the growth of the business.

The Role/Job Duties:

  • Quality oversight of the design, development, validation, implementation and ongoing maintenance and use of computerised GxP systems and IT infrastructure. Also, quality oversight of assessments, change controls, periodic reviews, investigations, deviations and CAPAs relating to computerised GxP systems.
  • Compliance support to global teams and sites as a subject matter expert. 
  • Provide data integrity program management, oversight and training for global teams, systems and sites.
  • Identify compliance and process improvements based upon internal and external audit observations and regulatory surveillance.
  • Collaborate on the development and maintenance of Global Quality and CSV Polices, Standards and Procedures as well as participate in associated roll out and training.
  • Participate in internal and supplier audits as a compliance, IT and CSV subject matter expert. Support regulatory and client audits of Catalent global systems and sites.

The Candidate

Education and Experience:

  • Bachelor’s Degree in Information Technology, Engineering, pharmaceutical sciences or related fields.
  • 3 to 5 years within the pharmaceutical, life sciences or related industry. 3 years in an IT, quality, regulatory or related operational role.  
  • Ability to travel domestically and internationally up to 25%
  • Experience with teams in a global multi-site environment. Fluency in a non-English languages a plus.

Knowledge/Skills Requirements:

  • Working knowledge of various pharmaceutical laboratory, manufacturing, packaging and quality systems and business processes (e.g., Empower 3, laboratory instrument systems, LIMS, Scada, Serialization, Trackwise, Documentum, ERP).
  • Working knowledge of applicable regulatory and industry guidance on GxP systems development, implementation, validation, maintenance, ongoing use and data integrity.
  • Working knowledge of computer infrastructure, servers, workstations, operating systems, databases.
  • Manage time and workload in a fast-paced, high-volume, multi-tasking work environment with limited supervisory guidance.
  • Professional with strong organisational, interpersonal, communication, presentation and problem-solving skills.
  • Confidently interact with personnel at all levels of the organisation from a variety of cultural backgrounds and manage/develop strategic relationships with suppliers and external partners.
  • Strong analytical, creative and critical thinking capabilities. Self-starter with the ability to work independently in an office, remote or non-office environment. Team player that is respectful of others, can work with and through others on cross-functional teams, can hold team members accountable and ensure compliant outcomes.

We will identify candidates based on the following:

  • Leads with Integrity and Respect
  • Delivers Results
  • Demonstrates Business Acumen
  • Fosters Collaboration and Teamwork
  • Champions Change
  • Engages and Inspires
  • Coaches and Develops

Position Benefits:

  • Join a high growth and fast paced organisation with a people focused culture
  • Global exposure, defined career path and annual performance review and feedback process
  • Competitive Medical, Dental, Vision and pension

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.
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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 [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.

Full time
  • Salary: £32,772
  • Salary Type: Per Annum

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Bolton, England, Greater Manchester, BL1, United Kingdom

  • Ad ID:  15436602
  • Ad Type:  Offered
  • Posted on:  30/08/2020, 03:09
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