Specialist, Quality Operations

**THE OPPORTUNITY**
- ** Be part of the team that ensures sustainable products meets standard quality and committed to deliver to customers worldwide**:

- ** Based in Singapore**, the regional hub for **Asia Pacific (AP) **and **top-ranked biopharmaceutical company on the Straits Times **and** Statista’s list of Best Employers in Singapore for three consecutive years (2021, 2022, 2023).**:

- Join the** premier biopharmaceutical company** that has been **in Singapore for more than 25 years and in AP for over 60 years.**

Our Quality group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

**What will you do**

The position of Specialist in Value Stream (VSM) Deviation Management provides end-to-end services and oversight for deviation investigations to IPT and Laboratory. The role will ensure and maintain high standards of quality and compliance within our organization.

In this role, you will be responsible for all or subset of the key responsibilities below:

- Perform root cause investigation on laboratory or quality related deviations using appropriate root cause analysis tools, identify appropriate Corrective Actions/Preventive Actions (CAPA) and write investigation reports.
- Review and approve manufacturing and laboratory related deviations.
- Review and approve manufacturing and laboratory related Corrective Actions/Preventive Actions (CAPA).
- Perform trend analysis related to deviations.
- Compile and report deviation related performance metrics.
- Provide deviation related training.
- Participate and support in any improvement initiatives related to deviation management.

**What you must have**

**Qualifications & Experience**
- Bachelor’s degree in Science/Life Science, Pharmaceutical Science, Engineering or proven relevant experience.
- Minimum 4 years of applied professional work experience in quality control/assurance in pharmaceutical manufacturing environment.
- Strong preference for previous quality / compliance experience, and previous deviation management experience.
- Competency in root cause analysis methods and tools. Excellent problem-solving skills, based on science, facts, data and understanding of regulatory requirements.

**WHAT YOU CAN EXPECT**
- Limitless opportunities across various areas in Manufacturing; well-structured career path
- A state-of-the-art facility that delivers solution to its customers world-wide

Our Manufacturing & Supply Division is committed to be the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create an interdependent global manufacturing network that’s committed to delivering a high quality, reliable supply to customers and patients on time, every time.

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

**Search Firm Representatives Please Read Carefully**

**Employee Status**:
Regular

**Relocation**:
**VISA Sponsorship**:
**Travel Requirements**:
**Flexible Work Arrangements**:
Not Applicable

**Shift**:
**Valid Driving License**:
**Hazardous Material(s)**:
**Job Posting End Date**:
10/24/2024

**Job Posting End Date**:10/24/2024

**Requisition ID**:R311489