The Global Regulatory Compliance team is responsible for implementing and sustaining a world class Quality Management System and ensuring that Catalent Pharma Solutions meets all customer and regulatory agency GMP/Regulatory requirements and expectations. The Catalent QMS establishes the requirements for how Catalent Pharma Solutions complies with all applicable regulations and guidance worldwide, including but not limited to, good manufacturing practice/quality systems requirements of the US Food and Drug Administration, European, South American, Asian (including Japanese and Chinese) and Australian agencies where Catalent sites are based and other International and/or local health authorities.
The Quality Specialist, IT Systems/CSV is responsible for supporting the infrastructure and processes for GMP/Regulatory compliance within Catalent Pharma Solutions, with particular emphasis on Quality oversight associated with CSS IT systems Project support.
The role will provide advice, guidance, support and information to Catalent projects and functions on CSV compliance with Catalent global Quality policies and cGMP. This role will ensure up to date application of modern CSV and compliance requirements applicable to computerized systems supporting Catalent GMP operations.
Quality oversight of Computer Validation for IT/CSV Systems Projects including review and approval of validation documentation, quality support and advice for projects.
Review and approve IT Change Controls.
Compliance and adherence to Catalent CSV policies and standards.
Education or Equivalent Requirements:
Bachelor’s degree in Computer Science, Business Administration, other Science related field
In lieu of Bachelor’s degree a minimum of 5 years of Quality or IT role supporting enterprise systems and 7 years total relevant experience will be considered.
Pharmaceutical and/or life sciences experience including Computer System Validation, 21 CFR Part 11 and general GxP experience preferred.
Knowledge, Skills and Abilities Required:
Demonstrated experience and excellent knowledge of applicable CSV and IT regulations including the US FDA CFR’s, EU, ICH, as well as the GAMP guidance.
Familiarity with computer infrastructure, servers, workstations, operating systems and data base management systems.
Familiarity with computerized pharmaceutical GMP systems such as LIMS, CDS, BMS, Analytical Instrumentation, Manufacturing and Packaging systems and associated vendors.
Creative and innovative ability.
Ability to work effectively under pressure and comply with timelines.
Specific vision requirements include reading of written documents and use of computer monitor screen frequently.
Professional with strong interpersonal skills.
Strong verbal and written communication skills; good presentation skills.
Willingness and ability for limited travel is required.
Catalent’s standard leadership competencies that are used to interview and for Performance & Development:
Leads with Integrity and Respect
Demonstrates Business Acumen
Fosters Collaboration and Teamwork
Engages and Inspires
Coaches and Develops
Diverse, inclusive culture
401(k) retirement savings plan with company match
19 days’ Paid time off
Medical, dental, and vision insurance
Flexible spending account
Employee discount programs
Robust Employee Referral Program
About Catalent Pharma Solutions
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? https://www.catalent.com/about-us/overview/