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The Aseptic Operations Manager leads all compounding and fill activities. Duties include oversight of business unit colleagues, direct accountability for setting the organizational direction, deploying resources, and leading performance, goal setting, and development activities. The role will work in partnership with the Pharmacist in Charge (PIC) to deliver a best in class production environment increasing safety, quality, manufacturing and financial performances.
Role Responsibilities:
- Ensuring safe work environments, enforcing operational discipline, and monitoring aseptic behaviors.
- Efficiently utilize tools and metrics (KPI’s) to monitor staff productivity, deliverables, timelines, and quality of work product to adjust staffing levels and operational processes as needed to ensure operational effectiveness.
- Support investigations, own CAPAs, and drive continuous improvements throughout operations.
- Responsible for developing staffs’ performance goals, maintaining positive employee morale and relations and managing paid time off
- Understanding of the importance/impact of cGMP standards.
- Responsible for handling disciplinary actions and/or Performance Improvement Plans, terminations, escalating complex employee issues to their manager or human resources and ensuring a fair and consistent approach with all team members.
- Identifying potential process/product improvements and working collectively with cross-functional teams to implement process/procedure updates.
- Demonstrates strong industry knowledge and comprehensive understanding of business processes.
- Demonstrates technical/functional expertise in applicable discipline and acquires knowledge in related disciplines.
- Actively working within cross-functional teams in order to improve overall performance through sharing knowledge in related disciplines while solving moderately complex problems.
- Utilize industry technical/functional experience to help develop standard operating procedures.
Ξεχωρίστε από το πλήθος
You possess the following qualifications, background and abilities:
- Minimum of a Bachelor Degree in a scientific, engineering, or business discipline required. Advanced degree/certification preferred. The position requires technical and business competency in all aspects of this job description.
- 5-8 years manufacturing or engineering experience, preferably in sterile manufacturing and a good understanding of quality and compliance requirements pertaining to cGMP and 21 CFR 210 & 211.
- 2-5 years management experience; with no fewer than 25 direct/indirect reports.
- Proven effective verbal and written communication skills
- Experience working with standard ERP/MRP systems.
- Experience interpreting compliance requirements and regulations is required.
- Knowledge of DEA, FDA and state regulations pertaining to manufacturing and handling of controlled substances.
Profile/Experiences:
- Able to establish robust processes, develop performance standards, track performance through fact driven exercises, and implement solutions to drive continuous process improvements.
- Demonstrates skills to solve complex problems in a wide variety of high pressure situations which require a high degree of ingenuity, creativity and innovativeness. In situations where precedent may not exist, is able to independently exercise judgment, determine appropriate solution and take action.
- Demonstrates a strong ability to be adaptable and flexible.
- Demonstrates proven knowledge of business and management principles.
- Previous experience working with auditors, inspectors, and regulatory agencies.
- Previous experience operating under FDA cGMP with a robust understanding of the principles and applications associated with manufacturing operations.
- Able to articulate difficult and complex situations in a comprehensive and succinct manner utilizing professional tools, and deliberate facts.
- Ability to drive a culture of partnership and accountability.
Τι προσφέρεται;
Fagron offers exciting opportunities for personal and professional growth. We provide an open and truly dynamic environment which supports and encourages you to develop your skills and talents.