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Qc Supervisor

3 weeks ago

Singapore Takeda Pharmaceutical Full time

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

**About the role**:

- Provide operational supervision in QC Microbiology and Lab Services, in driving the team to meet site specific objectives in Takeda Singapore.
- Ensure critical Microbiological operations and systems, lab service operations, sample management, consumables inventory management, purchasing management coordination and other coordination activities are in compliant with cGMP needs, regulatory requirements, corporate policies, division and site SOPs.
- To support the QC Lead (Microbiology) in achieving QC objectives, and strategic goals from a local and global perspective.

**How you will contribute**:

- To implement QC Systems such as purchase of and qualification of QC equipment.
- To ensure sufficient consumables/reagents to sustain daily operations and support the monument planning by driving equipment installation activities to completion per projects milestones.
- To provide oversight on control and administration of QC Systems related to the Microbiology and Lab Services areas e.g., sample receival/storage workflow, sample aliquoting, reagents/media/microorganism inventory management, 5S coordination/management, water testing, environmental monitoring etc.
- To provide management oversight on operational and resource planning for QC Microbiology Analysts and Lab Services Associates.
- To review and approve QC sampling/testing records.
- To provide technical coaching to the QC Microbiology and Lab Services team to ensure that manufactured products meet applicable regulatory standards.
- To approve GxP documents such as SOPs, Protocols, Technical Reports, Deviation Reports.
- To provide appropriate training for the QC Microbiology Analyst and Lab Services Associates.
- To initiate/lead laboratory deviations investigation.
- To provide technical oversight in troubleshooting during lab equipment failures.
- To coordinate/lead utilities system qualification and routine utilities testing activities
- To coordinate/lead routine and environmental monitoring qualification activities.
- To plan and coordinate the training of QC Microbiology Analysts and Lab Services Associates
- in all aspects of sample management, microbiological testing, instrumentation and methodologies.
- To make decision based on scientific and logical rationalization on behalf of the QC Lead (Microbiology) when required.
- To lead the 5S activities for the Microbiology Laboratory and Lab Services areas.
- To assist the QC Lead (Microbiology) in driving continuous improvement activities in the laboratory
- Upon delegation from the QC Lead (Microbiology), the QC Supervisor (Microbiology) may act on behalf to approve quality related items on behalf.
- To develop QC Microbiology Analysts and Lab Services Associates based on their career projection.
- To ensure responsibility in adhering to all applicable EHS requirements.
- To commit to a fair and respectful relationship to others and behavior in accordance with Takeda’s Code of Conduct.
- Any other duties as assigned by QC Lead (Microbiology).

**What you bring to Takeda**:
(a) Education and Experience Requirements
- Bachelor’s Degree in Biotechnology, Microbiology, 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.

(b) 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.
- Drive continuous improvement of QC operations.
- Ability to schedule tasks and activities for direct reports to meet timelines.
- Ability to perform resource planning to ensure sufficient resources available to support the business.
- Ability to manage activities assigned to his/her direct reports.
- To conduct appraisal and regular reviews with his/her direct reports.
- Assist the QC Lead (Microbiology) in budget planning and control for the QC Laboratory.

Technical Skills
- Has substantial knowledge and understanding in terms of regulatory standards requirements e.g.USP, EP, JP, Eudralex, 21CFR, ICH etc.
- Has substantial validation knowledge e.g., well verse in equipment and software validation life cycle
- Possess knowledge in Microsoft Office.

Problem solving
- Ability to solve problems and implements corrective actions using Six Sigma tools.
- Ability to presents in a timely manner major issue to the management with strategies on their
- resolution.
- Be a key leader/partner in solving critical product issues

**More about us**:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best