Packaging Change Control Manager in PA or NJ Job in Bridgewater 08807, New Jersey US
Candidate MUST be able to complete a 2 year assignment. Candidate may be based in Collegeville, PA OR Bridgewater, NJ ( individual's choice)
DESCRIPTION:
· He/ She will be responsible for the implementation of new or revised secondary packaging components and/or labeling artwork for Biopharmaceutical products.
· Will liaise between the Regulatory Strategy, Labeling Managers, and the geographically distributed artwork centers within Manufacturing to ensure regulatory timelines are met and product supply is not impacted.
· Responsible for tracking and real-time transparency to the artwork approval of final printed labeling for the Pharmaceutical Company portfolio.
RESPOBSIBILITIES:
· Gather and coordinate content for labeling artwork requirements within center disciplines (Marketing, Regulatory, Legal, Medical and Quality) in support of inline product maintenance changes; Consult with peers, as needed, to evaluate content of labeling updates to assess impact on packaging artwork.
· Communicate with Labeling Managers and/or Regulatory Strategy for documentation of labeling artwork timelines using Artwork Information Form.
· Advise Regulatory Strategy on target dates for artwork completion in conjunction with Manufacturing based on established guidelines.
· Evaluate manufacturing sites impacted by labeling updates.
· Initiate Artwork Requests, and ensure relevant regulatory documents are attached; Send Artwork Requests to all relevant Manufacturing sites; Upon receipt from Manufacturing, send Artwork Requests to other Change Control Managers for approval.
· Proactively pull proofreading projects from electronic Artwork and Labeling Management System (ePALMs).
· Proofread packaging and labeling artwork versus Editor’s Copies (EC’s) to comply with internal and external format and style guidelines.
· Evaluate packaging and labeling artwork updates, interpret information and ensure that changes have been applied consistently across products and product lines; Initiate discussions when artwork inconsistencies are discovered.
· Annotate packaging and labeling artwork using digital tools.
· Use appropriate judgment and approve or reject packaging and labeling artwork.
· Provide clear explanation to artwork center for accurate re-creation of artwork when needed.
· Negotiate proofreading due dates with customers when necessary; Communicate with Manufacturing on status of company’s Artwork Requests to ensure agreed upon timelines are met.
· Communicate with Regulatory Strategy on labeling artwork timelines as needed.
· Participate on departmental projects and cross-functional teams, as assigned.
· Evaluate content of labeling updates to assess impact on packaging artwork.
· Use biopharmaceutical packaging artwork knowledge, in combination with Trade Dress Style Guides and other guidelines while collaborating with manufacturing artwork centers to create accurate packaging Editor’s Copies.
· Identify appropriate Market Approvers for packaging artwork and electronically route for approval using electronic lifecycle management system; Interact and follow up with all Market Approvers, as needed, and address regulatory content issues as they arise during the approval process.
QUALIFICATIONS:
· Bachelor’s degree in an appropriate discipline, plus 2-6 years related work experience.
· Must be familiar with Regulatory environment, cGMPs and have an understanding of labeling regulations and controls.
· PC skills including spreadsheet, database management are required; Strong interpersonal, writing and verbal communication skills required.
· Demonstrated previous experience in proofreading of secondary packaging artwork and QC review of label content.
· Strong demonstrated project management and organizational skills; In depth knowledge of Manufacturing and site processes/requirements.
· Capacity to make appropriate business decisions when facing uncertainty.