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Qc Supervisor

3 weeks ago

Singapore Takeda Pharmaceutical Full time

**Job Title: QC Supervisor (Raw Material)**
**Location: Woodlands, Singapore**

**About the role**:
This position is required to:

- Lead the QC Raw Material Team and drive the team to achieve QC objectives.
- Ensure operations/systems are in compliant with cGMP, regulatory requirements, corporate policies, division and site SOPs.

**How you will contribute**:
Operations Management
- Routine management of the QC Raw Material Team in terms of operational control and resource planning in raw materials and water testing.
- Review and Approval of QC Records.
- Provides guidance, support and technical expertise to the QC Raw Material Team to ensure that testing are completed and performed as per stipulated turnaround time and meeting the applicable regulatory standards.
- Provide appropriate training and development for the QC Raw Material Team; including training of QC personnel in the Raw Material Laboratory on analytical QC Systems and methodologies related raw materials and water samples testing.
- Review and update competency matrix for analytical team periodically; ensure training in the team are completed based on individual competency map.
- Lead the QC Raw Material Team to improve safety performance and in driving Continuous Improvement Initiatives.
- Overall control and administration of QC Systems related to the Analytical areas e.g. chemical inventory management, 5S coordination/management, stability program, reagents/controls/reference standards qualification and management etc.
- Ability to supervise QC personnel in troubleshooting lab equipment failure used in the QC Raw Material Laboratory.
- Initiate/lead invalid results and laboratory deviations investigation; provide guidance to QC personnel in laboratory investigations related to raw materials and water samples.
- Participate and work with cross departments in cross function investigation related to raw material and water testing.
- Work with external laboratories and cross department (eg. QA, procurement, logistics) in raw material planning and testing, ensuring raw materials are released within the stipulated turnaround.

Continuous Improvement
- Assist the QC Lead (Analytical) in driving continuous improvement activities in the laboratory
- Participate in Operation Excellence initiatives and continuous improvement projects (eg. EFP walks, GEMBA and GMP walk)
- Participate and support in site and department strategic goals setting and implementation
- Lead the 5S activities for the Raw Materials Laboratory.
- Initiate and lead projects in improving safety performance

Project Management
- Work with MI&S in analytical equipment qualification activities for raw materials ensuring completion within the stipulated timeline.
- Work with MI&S in analytical method transfer activities for raw materials ensuring completion within the stipulated timeline.

General Responsibilities
- Make decision based on scientific and logical reasoning on behalf of QC Lead (Analytical) when required.
- Authorize to approve (on behalf of the QC Lead (Analytical)) QC Documents which include SOPs, Protocols, Technical Reports, Deviation Reports related to raw material and water testing.
- Participate and provide support in internal and external audit
- Upon delegation from the QC Lead (Analytical), QC Supervisor may approve quality related items on behalf of the QC Lead (Analytical).
- Ensure a safe working environment and QC Raw Materials Laboratory complies with all site EHS requirements.
- Develop QC Chemists and QC Analysts based on their career projection.
- Response to TCUs/TCOs alarm notifications and acknowledge these notifications with assessment actions when needed.
- Responsibility to adhere to any applicable EHS requirements.
- Commitment to a fair and respectful relationship to others and behavior in accordance with Takeda’s Code of Conduct.
- Any other duties as assigned by supervisor

**What you bring to Takeda**:
Education and Experience Requirements
- Bachelor’s Degree in biotechnology, Chemistry, Pharmacy or equivalent
- At least 5 years of experience in Pharmaceutical, Biopharmaceutical or related manufacturing environment, in which at least 1 year is in a supervisory role.
- Demonstrated ability to lead and manage a team to achieve objectives.
- Demonstrated strong project management capability.
- Demonstrated ability to collaborate with cross functional or cross sites to achieve objectives.

Key Skills and Competencies

Supervisory Skills
- Ability to lead and motivate direct reports to achieve QC Objectives.
- Provide leadership and guidance to the raw material team
- Ensure continuous improvement of QC operations
- Scheduling of tasks (eg. projects) and activities for direct reports to meet timelines.
- Resource Planning to ensure sufficient resources are available to support the manufacturing activities in raw materials and water testing in order to meet site’s objectives.
- Overall management of the activities assigned to his/her direct