Catalent Pharma Solutions Quality Specialist, Global Enterprise Systems in Somerset, New Jersey
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 (http://www.catalent.com/index.php/about-us/Catalent-Careers2)
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
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 www.catalent.com/careers to explore career opportunities.
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 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 (https://catalent.wd1.myworkdayjobs.com/External) 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 (https://www.youtube.com/playlist?list=PLuUGqEwwnH7hBwFlrsfSOH_raQHu4hOBK) .