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Senior Supervisor Parenteral Manufacturing – Isolation Technology

Senior Supervisor Parenteral Manufacturing – Isolation Technology
Empresa:

Bristol Myers Squibb


Lugar:

Manatí

Detalles de la oferta

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. Summary: Responsible for leading the Parenteral Vials and Syringes Isolation manufacturing process assuring compliance with applicable policies, regulations, and procedures. Meets budget objectives and productivity or process / line defects targets. Drive area projects to completion. Keep work pace and plan work schedules, set priorities with urgency and meet deadlines within a complex, rapidly changing environment. The incumbent must comply with Corporate and HR Policies, FDA, GMP, Environmental Health and Safety regulations and the current Good Manufacturing Practices required by the job function. Responsibilities: 1. Oversees resources availability (material, equipment, personnel – regular and lease workers) necessary to meet and comply with timely preparations, formulation and filling production plan. 2. Verifies adherence to procedures and Isolation Technology controls and provides corrective feedback during operations by frequent monitoring of production activities 3. Performs systematic walkthroughs of operation floors. 4. Ensures areas housekeeping and compliance with control areas facilities requirements 5. Establishes corrective actions plan to eliminate process deviations and documentation errors. 6. Supports efforts to release lots on hold and conducts thorough reviews of investigation reports. 7. Supports Annual Requalification Program by assuring on time execution of requalification activities. 8. Supports Environmental Monitoring and media fill Programs by assuring compliance with the corresponding procedure requirements 9. Defines job skill requirement for the manufacturing positions which includes back up operators for critical positions in the Isolation Technology environment and supports the training program design assuring adherence to training plan including employee certification and re-certification program. 10. Prepares and/or approves necessary SOP's and forms to be in full compliance with cGMP's and reflect manufacturing processes. 11. Supports Maintenance and Calibration Program by assuring on time execution of applicable preventive and corrective maintenance plans. 12. Provides process support to Technology Transfer activities in order to align it with the manufacturing needs 13. Supports the site Quality Systems and Compliance efforts 14. Review and approve new or existing products Regulatory Filings 15. Complies with Company Environmental, Health, and Safety goals programs and objectives. 16. Monitors scrap factor, equipment downtime, and labor utilization on a regular basis for effective and efficient production plan execution 17. Identifies opportunities to improve process performance and / or safety requirements. 18. Leads Continuous Improvement initiatives in the manufacturing area. 19. Generates and approve changes as per the established Change Control procedure. 20. Assists in preparing manufacturing budget, and establishes effective cost control programs to meet budget targets and objectives per company strategic plan. 21. Prepares on time performance reviews and manage disciplinary actions as needed. 22. Monitors attendance trends enforcing applicable Company policies and procedures. 23. Assesses and prepares development training in target areas in order to increase manufacturing technician's proficiency in current technology and assignments (e.g. FMEA Risk Assessment documents, RCA (root cause analysis), etc.) 24. Prepares work schedules and match employees with the required skill set for the jobs to be accomplished. 25. Coordinates daily Parenteral Lyophilization manufacturing activities and resources allocation including manufacturing areas sanitization (controlled and non-controlled areas), components preparation and lyophilization activities. 26. Provides continuity to the operations as required. 27. Verifies all the manufacturing documentation and ensure it is completed and in compliance. 28. Provides coaching and feedback to employees which includes employee disciplinary investigations and execution of disciplinary actions when necessary as per Company Policies. 29. Facilitates the coordination of any manufacturing related activities with support areas (eg. Maintenance, QA/QC, TS, SC, etc.) to ensure flawless execution on processes, equipment evaluations, product transfer and other activities. 30. Assists the Area Manager and the support groups to solve any production technical problem (eg. Process / equipment troubleshooting, QE's, CAPA's, yield, cycle time, quality and productivity). 31. Performs administrative functions such as personnel performance appraisals and development action plans, vacation schedules and approval, attendance (Kronos) administration for payroll processing, personnel leave of absences administration, budget activities and projections etc. 32. Performs as back up of the area Manager as required. Knowledge/Skill: Bachelor Degree in Science, Administration, or Engineering Five (5) years of experience in Compounding, Sterilization, Aseptic Filling and/or Lyophilization processes, and product transfer validation in a Pharmaceutical manufacturing environment, Three (3) years of solid supervisory experience, or leading teams (disciplinary actions, performance appraisals, development of succession plans, etc) or equivalent experience leading in a sterile manufacturing process. In depth knowledge in Aseptic Processing Strong Project Management skills Ability to lead continuous innovation initiatives, foster team building and simplify processes. Ability to prepare and understand technical documents such as FMEA's, Risk Assessments, Cause and Effect diagrams, Designs of Experiment (DOE) etc. Ability to maintain good employee relations and to handle grievances and complaints. Self-starter with strong leadership characteristics, analytical, administrative and people skills. Ability to communicate and work effectively in a team oriented environment. Knowledge of cGMPs, safety and environmental regulations, human resources and labor laws. Personal computer skills, knowledge in Excel, Word, PowerPoint, Internet. Fully bilingual oral and written (Spanish/English). Technical writing skills. Sense of urgency and business needs. Capability to use protective gowning Willing to work irregular hours, rotation shifts, weekends and holidays, when necessary. 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. SDL2017


Fuente: Adzuna_Ppc

Requisitos

Senior Supervisor Parenteral Manufacturing – Isolation Technology
Empresa:

Bristol Myers Squibb


Lugar:

Manatí

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