What are the responsibilities and job description for the Supplier Quality Specialist position at catalent?
Catalent Pharma Solutions are looking to recruit a Supplier Quality Specialist to join our team. The role will see you as an integral member of the Quality Network.
Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.
The Role
Manage the approved supplier list for Global Comparator, Depot and network site programs.
Plan, conduct, review and report supplier site and questionnaire audits including third-party and outsourced audits for new and existing domestic and international suppliers in line with Network procedures.
Ensure corrective action activities associated with all audit observations are agreed and completed in a timely manner.
Complete and assist in completion of Supplier Quality Agreements, Supplier Audits, (questionnaire and site), Risk Assessments, Risk Control Plans, License Review, Change Controls, Actions and Follow-up’s.
Ensure supplier records are current for all supplier approval documentation including audits, assessments, and quality agreements.
Evaluate and manage new supplier requests through to completion
Monitor supplier license renewal for applicable services.
Perform impact assessments and execute action plans for supplier change notifications (i.e. facility change, supplier change controls)
Evaluate supplier notifications for potential impact to internal processes and client commitments.
Present concise and accurate information for queries on external audits as required
Participate and/or lead continuous improvement activities related to Global programs across the Catalent Global CSS network
The Person
A Bachelor’s Degree in a scientific or engineering discipline with some experience in pharmaceutical quality, or an equivalent combination of education and experience.
Prior Supplier Auditing experience and experience in writing supplier audit reports, certified auditor or lead auditor credentials are preferred.
Experience and sound knowledge of GMP/GDP/GCP regulations, especially those related to comparator sourcing, wholesaler licensing, third party storage and distribution preferred.
Prior experience in JDE and Trackwise systems preferred
Ability to work independently with strong goal orientation and sense of responsibility.
Strong process improvement mindset, strategic business perspective and critical thinking capability.
Demonstrate project management skills with an ability to prioritize, plan, evaluate & execute deliverables for established tactical goals.
Strong follow-up skills and attention to detail.
Ability to lead cross-functional teams.
Competence in both written and verbal communication.
Excellent verbal and written communication and presentation skills with the ability to comprehensively read, write, and speak English.
Influence and make recommendations at multiple levels of the company, be decisive when required on product quality issues to ensure compliance.
Located within a commutable distance to International Airport.
Ability to travel both domestic and abroad to Catalent sites or Catalent supplier locations as required ~25% travel
This is a site based position in either Bathgate, Scotland or Shorndorf, Germany
Why you should join Catalent
Competitive Salary
Opportunities to join Employee Resource groups and be involved in charity events
Other benefits depend on whether UK/EU based
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 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.
