Assoc. Specialist, 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 Statistas list of Best Employers in Singapore for two consecutive years ().
• 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.

Others

• Review and approve batch sheets (electronic /paper)
• Review and approve shopfloor E-logs EMS alarm reports trend reports
• Review and approve assigned deviation reports
• Review and approve SOPs/WI/E-logs
• Perform quality monitoring on shopfloor in assigned shift during aseptic process simulation runs.
• Perform other tasks 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 thats 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 worlds 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 usand 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 anothers thinking and approach problems collectively. We are an equal opportunity employer committed to fostering an inclusive and diverse workplace.

Required Skills:

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:

Relocation:

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Travel Requirements:

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