Summary
Date Posted: Friday, January 05 2024, Base Salary: Not Disclosed

JOB DETAILS:
JOB SUMMARY
The role of a Production Manager in a medical devices manufacturing facility is to supervise the manufacturing and production processes of medical devices.

DUTIES AND RESPONSIBILITIES
• Analyzing production data and metrics to identify trends, issues, and opportunities for process improvements.
• Set daily/weekly/monthly objectives and communicate them to employees
• Organize workflow by assigning responsibilities and preparing schedules
• Oversee and coach employees
• Ensure the safe use of the equipment and schedule regular maintenance
• Check production output according to specifications
• Ensuring compliance with environmental, health, and safety regulations and guidelines.
• Developing and implementing policies and procedures that improve production efficiency, quality, and safety.
• Ensuring that manufacturing processes and equipment are maintained and repaired to minimize downtime and ensure high levels of productivity.
• Enforce compliance with QA processes, Equipment Qualification, and Computer System Validation principles. Support all regulatory and customer quality audits.
• Gather, organize & analyze data to develop solutions & alternative methods of proceeding; execute continuous improvement projects to optimize operations to deliver process improvements
• Assist CAPA teams, and other project teams, in the development of action plans and implementation schedules, and the verification of completed actions.
• Identify compliance issues that require follow-up or investigation.
• Conduct or direct the internal investigation of compliance issues.
• Conduct or direct the internal investigation of customer complaints.
• Track compliance issues within all departments and ensure completion within defined timelines.
• Assess product, compliance, or operational risks and develop risk management strategies.
• Disseminate written policies and procedures related to compliance activities.
• File appropriate compliance reports with regulatory agencies.
• Evaluate testing procedures to meet the specifications of environmental monitoring programs.
• Verify that software technology is in place to adequately provide oversight and monitoring in all required areas.
• Maintain documentation of compliance activities, such as investigation outcomes.
• Consult with corporate attorneys as necessary to address difficult legal compliance issues.
• Discuss emerging compliance issues with management or employees.
• Advise internal management or business partners on the implementation or operation of compliance programs.
• Provide assistance to internal or external auditors in compliance reviews.
• Prepare management reports regarding compliance operations and progress.
• Monitor compliance systems to ensure their effectiveness. Oversee internal reporting systems such as corporate compliance hotlines and inform employees about these systems.
• Develop or implement environmental compliance plans for programs, such as air, surface and personnel sampling.
• Set daily/weekly/monthly objectives and communicate them to employees,
• Organize workflow by assigning responsibilities and preparing schedules,
• Oversee and coach employees, Ensure the safe use of equipment and schedule regular maintenance,
• Check production output according to specifications, Train new employees on how to safely use machinery and follow procedures

Qualifications & Experience
• BSc. in science-related fields such as Pharmacy, Chemical/Mechanical/Biomedical Engineering, and Biotechnology.
• 5+ years of production in BioPharma/biotech or similar technology-based industries such as cell and gene therapy.
• Experience with SAP for production & manufacturing a plus
• The applicant should have a High degree of integrity.
• Ability to work as part of a team.
• Ability to deliver accurate results in a timely manner and in an environment with multiple and challenging tasks.
• Knowledge of Occupational Safety and Health Administration regulations
• Strong verbal and written communication skills



Work Hours: 8

Experience in Months: 60

Level of Education: Bachelor Degree

Job application procedure

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