Summary: Accountable for providing operational, scientific expertise and compliance knowledge support to the Sterile or Non Sterile Manufacturing Operations. Also accountable for the execution and completion of investigations task items, Corrective Action Preventive Action (CAPAs), This incumbent must comply with all Security guidelines, Environmental Health and Safety regulations and the current Good Manufacturing Practices required by the job functions. Responsibilities: 1. Ensures that all investigation task items, Change Controls/Change Actions and CAPAs are completed / closed within the established timeframe, utilizing the right tools to prevent reoccurrence. 2. Reviews and provides input to regulatory submissions applicable to area of responsibility. 3. Leads investigation task items and CAPAs Change Controls trend evaluation. 4. Participates in the new product introduction process to determine requirements for documentation, materials, training, equipment modifications, and document revisions. 5. Facilitates the necessary information related to the support of the existing processes, the fast tracking for documenting, implementing process modifications and technology for products transfers and validation. 6. Supports establishment of process monitoring parameters and control limits. 7. Supports the assessment of deviations and process monitoring data. 8. Monitors and evaluates parameters in existing (on-going) processes to optimize process times/productivity, equipment performance, yields and quality. 9. Provides technical assistance to identify, recommend and implement process and equipment modifications to improve process performance; to identify and assist in the implementation of cost reduction projects and assuring the manufacturing area is in cGMPs compliance. 10. Writes, evaluates and revises the required manufacturing documentation (i.e. SOPs, MBRs, etc.) and may assist in providing training on scientific or technical aspects of the processes. 11. Assists with generation and execution of validation protocols and reports. 12. Participates in regulatory inspection when necessary. 13. Leads the execution of CAPAs, including identifying response plan, execution and revision of associated documentation. 14. Generates and executes completion of Change Controls related to manufacturing processes/systems/improvements; procedures development & revision, process validation documentation and execute Change Actions from area-related Change Controls. 15. Assists the area managers and supervisory personnel to solve any production technical problem (i.e. Process / equipment troubleshooting, yield, cycle time, quality and productivity). 16. Provides alternatives and recommendations to improve and maximize processes and equipment. 17. Participates in Environmental Regulatory and Compliance Permits and Process Safety Hazards evaluation. 18. Promotes and models the BMS Core Behaviors, facilitating teamwork. 19. Supports all site initiatives and any other assignments based on business needs. Knowledge/Skill: BS Degree in Science, Pharmacy and/or Engineering Five (5) years of experience in a Parenteral Manufacturing operation facility Broad working experience with Change Controls/Change actions and CAPA Experience with validation protocols Strong technical writing and presentation skills Ability to interpret and analyze statistical data Knowledge in CGMPs, OSHA, EPA and other regulatory standards Knowledge of computers applications (Microsoft Word, Excel, Power Point) Excellent leadership and interpersonal skills Team work oriented Excellent communications skills in Spanish /English
Ciudad: manatí
