Associate Specialist, Quality Assurance

MSD INTERNATIONAL GMBH (Singapore Branch); Singapore; On-site; SGD 60,000 - 70,000; Full time

Job summary

A leading biopharmaceutical company in Singapore is seeking a Quality Assurance professional with a Bachelor's Degree and a minimum of 3 years in the pharmaceutical industry. The role involves batch review, deviation tracking, and change control management. The ideal candidate will have a solid understanding of GMP and regulatory standards, excellent problem-solving skills, and the ability to work in a multicultural environment. Join us to contribute to high-quality bio-pharmaceuticals delivered worldwide.

Qualifications

• Minimum of 3 years experience within the pharmaceutical industry.
• Good knowledge of GMP and pharmaceutical regulatory requirements.
• Strong preference for previous quality/compliance experience.

Responsibilities

• Reviews and closes batch records.
• Collaborates with operations to improve batch record errors.
• Tracks and ensures completion of corrective actions.

Skills

Problem solving skills

Interpersonal skills

Leadership skills

Collaboration skills

Education

Bachelor's Degree in Science/Life Science/Pharmaceutical Science or Engineering

Job description

THE OPPORTUNITY

• Be part of the team that ensures sustainable products meets standard qualityand 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 listof Best Employers in Singapore for two consecutive years (2020, 2021).
• Join the premier biopharmaceutical company that has been in Singaporefor more than 25 years and in AP for over 60 years.

Our Quality Assurance group ensures every single materialinside our products is manufactured, processed, tested, packaged, stored anddistributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturingfacilities, external contract manufacturers and suppliers we create aninterdependent 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 fromquality 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 actionplans for identified audit issues, identify the non-compliance issues andproactively collaborate with the relevant department to resolve issue.
• Work closely with other functional groups to raise the level of awarenesstowards cGMP, company policies and procedure, regulatory guide and codes
• Participate in continuous improvement initiative as part of the MPS culture inthe company in Singapore.
• Participate in EHS, Business Compliance, cGMP and all other compliance-relatedmatters, where applicable.
• Perform any other tasks as assigned by manager.

WHAT YOU MUST HAVE

To be successful in this role, you will have:

• Bachelor's Degree in Science/ Life Science, Pharmaceutical Science or Engineering orproven relevant experience.
• Good knowledge and understanding of GMP and application of pharmaceuticalregulatory requirements.
• Strong preference for previous quality / compliance experience, and previouscomplaint 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 ofregulatory requirements.
• Strong demonstrated interpersonal, communication, collaboration and leadershipskills; 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 customersworld-wide

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

Who we are…

We are known as Merck & Co., Inc., Rahway, New Jersey,USA in the United States and Canada and MSD everywhere else. For more than acentury, we have been inventing for life, bringing forward medicines andvaccines for many of the world's most challenging diseases. Today, our companycontinues to be at the forefront of research to deliver innovative healthsolutions and advance the prevention and treatment of diseases that threatenpeople and animals around the world.

What we look for…

Imagine getting up in the morning for a job as important ashelping to save and improve lives around the world. Here, you have thatopportunity. You can put your empathy, creativity, digital mastery, orscientific genius to work in collaboration with a diverse group of colleagueswho pursue and bring hope to countless people who are battling some of the mostchallenging diseases of our time. Our team is constantly evolving, so if youare among the intellectually curious, join us—and start making your impacttoday.

We are proud to be a company that embraces the value ofbringing diverse, talented, and committed people together. The fastest way tobreakthrough innovation is when diverse ideas come together in an inclusiveenvironment. We encourage our colleagues to respectfully challenge oneanother’s thinking and approach problems collectively. We are an equalopportunity employer, committed to fostering an inclusive and diverseworkplace.