Implementing the QA policy relative to the entire Packaging Artwork creation and modification work-flow, from beginning to end
Ensuring the use of packaging in accordance with the destination market(s)
Ensuring the control fo the developments in terms of packaging consistency with regulatory changes
Ensuring the control of re-packaging (including relabeling) operations
As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.
Duties & Responsibilities:
Implementing the QA policy relative to the entire packaging artwork flow, from creation to start of production
Define the quality system within the Packaging Artwork Management teams in order to develop procedures that will secure and guarantee compliance of the processes used for information exchange in the curse of packaging creation and amendments within BI AH global processes (Change Control, Product Readiness, Lifecycle Management) and in close cooperation with Global BI Quality teams; e.g. implementing packaging specifications and procedures in collaboration with site Operations.
Secure and make sure Packaging Artwork processes are compliant to pharmaceutical requirements
Build, educate and implement with all actors (internal , external) impacted by packaging components, efficient worldwide workflows / procedures / policies and best in class practices to maximize success rate and minimize time and risks
Ensuring the use of packaging in accordance with the destination markets
Develop and control the policy which assure that appropriate packaging, labels and shelf life are used for products which were released for a said country/group of countries, i.e. conform to marketing authorization (product license, registration certificate) - legal document issued by the competent drug regulatory authority.
Develop and control the policy which assures that products which were released for a said country/group of countries are shipped only to that country/group of countries, and that any exception is cleared by QA/QP.
Responsible for Global audit in order to verify that arrangements are made for the manufacture, supply and use of the correct packaging materials.
Participate in the development of a rigorous process in order to minimize the risk of counterfeit drugs.
Ensuring the control of the developments in terms of packaging consistency with regulatory changes
Develop and control the policy which assures that packaging and labels confirm to marketing
Authorization change requests and are set up and distributed in local or global markets.
Ensure the appropriate involvement of BI AH functions within development/review of workflows/procedures / policies / best practices
Ensure that appropriate parties within site Operations at all sites impacted are notified following Health Authorities approvals, when the approved changes may/ must be implemented.
Ensure that compliance is not compromised between country requirements and the procedures used at the manufacturing site
Ensure that appropriate Contract Manufacturing Operations (CMO) is notified of proposed changes and copied on all Change Controls affecting products handled by the relevant CMO unit
Ensuring the control of re-packaging (including relabeling) operations:
Assure that Repackaging (including relabeling) of pharmaceutical products is only performed by distributors/ subcontractors appropriately authorized and/or licensed to do so, and in accordance with GMP principles
Assure that these operations are performed in compliance with the applicable national, regional and international guidelines and/or legislation relating to repackaging and relabeling of pharmaceutical products
Set up policy to check that the presentation after repackaging will not damage the reputation of BI AH, so not to effect the original condition of the product, including the inclusion of instructions and information
Define the appropriate level of information (e.g.: template of a batch record which has to be returned to the manufacturing site of origin.
Responsible of the evaluation and compliance (Due Diligence) for repacking and relabeling subcontractor
Coordinate all technical due diligence assessments in concert with other functions of the site QA organization
Master degree or Bachelor degree from an accredited institution in Science or Business related field
Three to five-plus (3-5+) years’ experience in Supply Chain or Commercial Operations
Fully understand and apply all BI AH regulations and policies on Health, Safety and Environment
Manages, trains and motivates all accountable personnel in accomplishing corporate goals and objectives within company policy guidelines
Provides technical skills training to the team and its customers
Lead Packaging Operational Group managers through a process that will secure packaging compliance worldwide
Promote a proactive and responsible image for BI Quality with regulatory / CMC, supplier community and external stake-holders
Manage the development and the implementation of new regulation, control the site conformity with new regulation
Business fluent in English
Strategic Business and Operations mindset
Highly organized and proficient project manager with history leading cross-functional teams
Great inter-personal skill, professionalism & assertiveness
Ability to effectively drive change while maintaining and enhancing internal customer relationships
Strong negotiation skills
Must be legally authorized to work in the United States without restriction.
Must be willing to take a drug test and post-offer physical (if required)
Must be 18 years of age or older
Who We Are:
At Boehringer Ingelheim we create value through innovation with one clear goal: to improve the lives of patients. We develop breakthrough therapies and innovative healthcare solutions in areas of unmet medical need for both humans and animals. As a family owned company we focus on long term performance. We are powered by 50.000 employees globally who nurture a diverse, collaborative and inclusive culture. Learning and development for all employees is key because your growth is our growth.
Want to learn more? Visit boehringer-ingelheim.com and join us in our effort to make more health.
Boehringer Ingelheim, including Boehringer Ingelheim Pharmaceuticals, Inc., Boehringer Ingelheim USA, Boehringer Ingelheim Animal Health USA, Inc., Merial Barceloneta, LLC and Boehringer Ingelheim Fremont, Inc. is an equal opportunity and affirmative action employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender identity or expression; affectional or sexual orientation; disability; veteran or military status, including protected veteran status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
Job - Quality
Primary Location - Americas-US-GA-Duluth
Organization - US-Vetmedica
Schedule - Full-time