Bristol-Myers Squibb is a global Biopharma company committed to a single mission : to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.
Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development.
Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.
This position is responsible for the on line / off line review and approval, from DPO standpoint, of manufacturing batch records associated to all manufacturing process.
Review and approval of process related documentation such as Log Books, Cleaning Forms within others and overlook manufacturing activities to assure that are carried out within the framework of corporate / governmental policies and regulations (cGMP's).
The incumbent must comply with all Security guidelines, Environmental Health and Safety regulations and the current Good Manufacturing Practices, required by the job function.
1. Reviews procedures, batch record and / or forms to assure update with current practice, audits or cGMP and to address requirements of corrective and prevention actions (CAPAs).
2. Performs batch record reviews for the manufacturing different stages in order to ensure compliance with established procedures and documentation requirements, as well as cGMP regulations.
3. Audits the executes batch record for all products manufactured at the site. This involves but not limited to the review of product and components reconciliation, completeness and correctness of information, in-process testing, sampling, expiration date, operation sequence and repeatability of the process.
4. Alerts management on trends noted on evaluated process and verify actions taken in order to restate control and participate on the prevention and identification of root causes and internal complaints to pursue permanent corrective measure
5. Evaluate reports and documents the nature of incident and / or deviations at the time of occurrence of during document verification in order to determine immediate corrective actions to be taken and follow up on the investigation cause corrective / preventive actions and documentation requirements.
6. Categorize and reports documentation errors and deviations in order to aware management of trends and focus on the required corrective measure.
7. Support investigations providing supplemented information related to Sterile Operations events.
Knowledge / Skills :
1. B.S. in Natural Science (Chemistry, Microbiology, Biology) or related fields.
2. At least 1-2 years of experience in a regulated environment. Manufacturing or Quality experience, preferable in a documentation function.
3. Computer literate (knowledge on Microsoft Word, Microsoft Excel, Microsoft Power Point, QC-Main and SAP).
4. Must exercise accurate judgment and be able to evaluate information critically and decide upon appropriate course of action.
Must be able to correlate events and determine the action plan required to avoid incidents recurrence and apply them.
5. Knowledge of compendia requirement and cGMP, FDA regulations and the ability to interpret and apply them.
6. Must possess good verbal and written communication skills in English and Spanish
7. Capable to manage multiple priorities.
Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.