Sr Supervisor Parenteral Manufacturing Isolation Technology at (BMS) Bristol-Myers Squibb
Posted in General Business 30+ days ago.
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Location: Manati, Puerto Rico
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.
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. Performs as back up of the area Manager as required.
• Bachelor Degree in Science, Administration, or Engineering
• Five (5) years 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 multidisciplinary teams ( disciplinary actions, performance appraisals, development of succession plans, etc).
• 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.