KEY DUTIES AND RESPONSIBILITES:
· The Aseptic Operations Manager leads all compounding and sterile fill activities. The role is also responsible for secondary packing of final finished goods.
· 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.
· Utilize industry technical/functional experience to help develop standard operating procedures.
REQUIREMENT
· 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 highly regulated environments.
· Previous experience working with auditors, inspectors, and regulatory agencies.
· 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.
EDUCATION & EXPERIENCE
- Minimum of a Bachelor Degree in a life science, pharmacy, or engineering discipline required. Advanced degree/certification preferred. It will be an advantage to the candidate if he/she is a registered pharmacist in Singapore.
- 5-8 years manufacturing or engineering experience, preferably in sterile manufacturing and a good understanding of quality and compliance standards of various agencies, including US-FDA, European EMA and China NPMA.
- 3-5 years management experience; with no fewer than 20 direct/indirect reports.
- Proven effective verbal and written communication skills
- Experience working with SAP, QMS such as TrackWise
