Senior Analyst, Manufacturing & Packaging Documentation at Daiichi Sankyo, Inc. in Basking Ridge, New Jersey

Job Description:

Join a Legacy of Innovation 110 Years and Counting!



Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. Under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.



Summary



This role will require the learning and complete understanding of all facets of the artwork and specification processes used within DSI. The role will provide input into document management systems, and processes to ensure compliance with Current Good Manufacturing Practices. The role will also be heavily involved in artwork creation, changes, and approval for packaging components across the DSI product line and will provide subject matter expertise for product projects as needed.



Responsibilities



- Documentation Management


Maintain product, packaging component and artwork sample supplies. Manage both electronic and hard copy documentation within existing systems or physical areas.Maintain current and future document management systems, policies and procedures that apply to and support Supply Chain Technical Operations (SCTO).Collaborate with CMOs to create specification content for secondary packaging components and assist with management of the review and approval process of the documents. Make recommendations for any changes that may be required and then implement the changes once aligned.
- Change Management Process


Assist in review, make recommendations for updates and facilitate approval of CMO documentation such as bills of materials and change controls related to component changes. Initiate change control documentation and monitor approval process to ensure timely reviews. Attend CMO meetings as required. Provide information regarding changes and partner with CMO associates and internal functions to determine best dates for implementation.
- Training Management
Maintain department GxP training requirements.
oReview GxP SOPs for impact to established curricula. Make recommendations for changes/updates and assist in implementation of changes.


oConduct annual curricula review to assure GXP training requirements accurately reflect each role. Make recommendations for any updates that may be required.


oCollaborate with Global QA Training Operations to ensure curricula are accurate in the training management system.


Represent Supply Chain as a subject matter expert in bi-monthly Global GxP Training Operations Meeting.
- Artwork Process


Collaborate with Regulatory Affairs, approved vendors, and printers to create print ready artwork and proofs assuring proper layouts, artwork meets requirements for CMO needs and is compliant with current regulatory approvals, regulatory guidelines, and established component specifications. Initiate the review and approval process for artwork in accordance with department SOPs. Compile data for annual product reviews related to artwork changes and provide compiled data to the Regulatory function for submission..



Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.



Education Qualifications (from an accredited college or university)



- Bachelor's Degree in Business, Science, Library Science, Data Management or related field is required required



Experience Qualifications



- 1 or More Years 2-3 years in documentation management; knowledge of cGMP's required
- Knowledge of labeling regulations preferred
- Knowledge of print production preferred
- APICS certification preferred



Travel



Ability to travel up to 5%. Primary travel to domestic contract manufacturing locations and to global DS sites as required


Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.