Assoc. Specialist, Quality Assurance at Merck Sharp & Dohme Corp. /Netherlands

Singapore, Singapore, Singapore -

Full Time

Start Date

Immediate

Expiry Date

21 Mar, 26

Salary

0.0

Posted On

21 Dec, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Accountability, Analytical Problem Solving, Aseptic Filling, Biopharmaceutical Industry, cGMP Compliance, Communication, Complaint Management, Decision Making, Deviation Management, GMP Compliance, Quality Assurance, Quality Management, Quality Standards, Quality Support

Industry

Pharmaceutical Manufacturing

Description

Job Description 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 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 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. Participate in EHS, Business Compliance, cGMP and all other compliance-related matters, where applicable. Perform any other tasks as assigned by manager. WHAT YOU MUST HAVE To be successful in this role, you will have: Bachelor 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 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. 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 a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world. 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. Required Skills: Accountability, Accountability, Analytical Problem Solving, Applied Engineering, Aseptic Filling, Biopharmaceutical Industry, Biopharmaceutics, cGMP Compliance, Communication, Complaint Management, Decision Making, Deviation Management, GMP Compliance, Good Manufacturing Practices (GMP), Healthcare Innovation, Manufacturing Compliance, Pharmaceutical Guidelines, Pharmaceutical Sciences, Quality Assurance (QA), Quality Auditing, Quality Management, Quality Management Standards, Quality Management Systems (QMS), Quality Standards, Quality Support {+ 4 more} Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Temporary (Fixed Term) Relocation: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Not Applicable Shift: Valid Driving License: Hazardous Material(s): Job Posting End Date: 02/17/2026 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

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Responsibilities

The role involves batch review and disposition, collaborating with operations to improve batch record errors, and participating in investigations related to deviations and customer complaints. Additionally, the specialist will review and approve change control requests and collaborate with various departments to ensure compliance with quality standards.