Specialist, Quality Assurance

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 two consecutive years (2020, 2021).
• Join the premier biopharmaceutical company that has been in Singapore for more than 25 years and in AP for over 60 years.

Our Quality Assurance 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 allregulatory 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

WHAT YOU WILL DO:

Batch Review/Batch Disposition

• Reviews and closes batch record
• Collaborates with Operations team to improve the batch record errors which includes trending analysis
• Performs batch disposition in SAP system and issues related batch disposition documentation
• Communicates to Qualified Person/Qualified Release Personnel on any information that may result in revoking of released status of any shipped material
• Discussion with Qualified Person/Qualified Release Personnel periodically related to batch disposition
• Provides Batch Review/Batch Disposition related training and serve as subject matter expert (SME) for batch review in the respective area
• Act as coordinator with IPT & SCM for review and release.

Deviation/OOS/Customer Complaints

• Participates in investigations, reviews and approves investigation reports.
• Tracks Corrective Actions/Preventive Actions and ensures timely completion.
• Generates deviation summary reports.
• Performs trend analysis of root causes on a periodic basis.
• Reviews and closes completed OOS.

Change Control

•  Reviews and approves change control request, qualification activities from quality perspective.
• Acts as Quality representative in change control meetings.
• Reviews change control (ACC, ECC, PCR).

Others

• Reviews and approves batch-sheet (new and changes).
• Reviews and approves SOPs, Forms, and procedures.
• Reviews and approves cleaning protocol, cleaning reports, and cleaning records.
• Collaborates with other functional department in each plant to develop action plans for identified audit issues, identify the non-compliance issues and proactively collaborate with the relevant department to resolve issue.
• Work closely with other functional groups to raise the level of awareness towards cGMP, company policies and procedure, regulatory guide and codes
• Participate in continuous improvement initiative as part of the MPS culture in the company in Singapore.
• Participatein EHS, Business Compliance, cGMP and all other compliance-related matters, where applicable.
• Perform any other tasks as assigned by manager.
• To independently solve problems that arise within job responsibilities and expectation; organize information in logical ways and combine data and information from multiple sources in new ways to determine causes of issues by applying knowledge of technical and scientific knowledge, statistical data evaluation.
• Develop and oversee plans for all activities related to local/regional deviation management projects including connection to product recalls and clinical stock recoveries.
• Maintains appropriate quality oversight of SOPs for manufacturing and operational activities.
• Approve IQ, OQ, and PO protocols for moderately complex systems. Identifies validation issues and supports development of remedial actions.
• Actively participates in the projects till its completion.

WHAT YOU MUST HAVE

To be successful in this role, you will have:

• Bachelor's Degree in Science/ Life Science, Pharmaceutical Science or Engineering or proven relevant experience.
• Good knowledge and understanding of GMP and application of pharmaceutical regulatory requirements.
• Strong preference for previous quality / compliance experience, and previous complaint experience. 
• Minimum of 3 years experience within the pharmaceutical industry. 
• Requires ability to identify and implement continuous improvement initiative.
• Excellent problem solving skills, based on science, facts, data and understanding of regulatory requirements.  
• Strong demonstrated interpersonal, communication, collaboration and leadership skills; and ability to work in a multi-cultural environment. 

WHAT YOU CAN EXPECT

• Limitless opportunities across various areas in sterile Manufacturing 
• 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 biopharmaceuticals 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.

What we look for…

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.

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.