Job Description

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Job Title: QC Supervisor (Analytical)
Location: Woodlands, Singapore

Reporting to: QC Lead (Analytical)

About the role:

This position is required to:

Lead the QC Analytical 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 Analytical Team in terms of operational control and resource planning in bulk drug substances testing.

Review and Approval of QC Records.

Provides guidance, support and technical expertise to the QC Analytical Team to ensure that manufactured products testing are completed and performed as per stipulated turnaround time and meeting applicable regulatory standards.

Provide appropriate training and development for the QC Analytical Team; including training of QC personnel in the Analytical Lab on analytical QC Systems and methodologies.

Review and update competency matrix for analytical team periodically; ensure training in the team are completed based on individual competency map.

Lead the QC Analytical 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 Laboratory.

Initiate/lead invalid results and laboratory deviations investigation; provide guidance to QC personnel in laboratory investigations related to manufactured products.

Participate and work with cross departments in cross function investigation related to the Analytical Areas.

Work with cross sites in manufactured products testing to ensure testings are completed within the testing turnaround time.

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\xe2\x80\x99s Code of Conduct.

Any other duties as assigned by supervisor

What you bring to Takeda:

Education and Experience Requirements

• Bachelor\xe2\x80\x99s 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\xe2\x80\x99s objectives.

Overall management of the activities assigned to his/her direct reports.

Conduct appraisal and regular reviews with his/her direct reports.

Assist the QC Lead (Analytical) in the budget planning and control for the QC Laboratory (Raw Material).

Project Management Skills

Organization and planning skills

Analytical and logical thinking skills

Ability to work and collaborate within the team and with cross departments

Technical Skills

Has good knowledge and experience with raw material testings, GMP laboratory operations for common pharmacopoeia testing methods and equipment (eg. wet chemistry, gas chromatography, heavy metals, residual solvents)

Has substantial knowledge and understanding in terms of regulatory standards requirements e.g. USP, EP, 21CFR, ICH etc.

Validation knowledge e.g. well verse in equipment and software validation life cycle

Knowledge in Empower and LIMS.

Knowledge in Microsoft Office.

Problem solving

Solves problems and implements corrective actions using six sigma tools.

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

Safety

Knowledge of Safety principles, practices, regulations and procedure related to the work.

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Empowering our people to shine:

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, or any other characteristic protected by law.

Locations

SGP - Singapore - Woodlands

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Takeda