Senior Specialist-Aseptic
1 day ago
KEY DUTIES AND RESPONSIBILITES:
- The role involves leading all compounding and sterile filling activities, as well as being responsible for the secondary packaging 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.
Tell employers what skills you have
Microsoft Office
Microsoft Excel
Administration
Compounding
Payroll
Employee Engagement
SAP
Compliance
Packaging
HR Policies
Accountability
Articulate
Human Resources
Manufacturing
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