Assoc. Spclst, Quality Assurance

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'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 1-3 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.

Required Skills:

Analytical Problem Solving, Analytical Problem Solving, Aseptic Filling, Biopharmaceutical Industry, Biopharmaceuticals, Biopharmaceutics, cGMP Compliance, Complaint Management, Continuous Process Improvement, Creating Action Plans, Decision Making, Deviation Management, Disease Prevention, Global Manufacturing, GMP Compliance, Good Manufacturing Practices (GMP), Pharmaceutical Microbiology, Pharmacy Regulation, Quality Auditing, Quality Management Standards, Quality Management Systems (QMS), Quality Standards, Quality Support, Regulatory Requirements, Root Cause Analysis (RCA) {+ 2 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:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Not Applicable

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

06/30/2026

*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.