Job Description

Work Your Magic with us!

Ready to explore, break barriers, and discover more? We know you\'ve got big plans - so do we! Our colleagues across the globe love innovating with science and technology to enrich people\'s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That\'s why we are always looking for curious minds that see themselves imagining the unimaginable with us.

A career with Our Company is an ongoing journey of discovery: our 50,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.

Who we are: Our Company is a leading science and technology company. Its life science business offers a broad range of innovative products and services to biotech and pharmaceutical drug therapies businesses. Through dedicated collaboration with the scientific and engineering communities, and as one of the top three R&D investors in the life science tools industry, the brand serves as a strategic partner to customers and helps advance the promise of life science.

Your role: The individual performs a variety of tasks within the Quality Assurance department including conducting audits and review / approval of various types of regulated documentation.

Scope of Responsibility: Impacts a range of important customer, operational, project or service activities within the Quality Assurance (QA) team as well as Operations teams. Solves problems of varying complexity independently by identifying and selecting solutions and by analysing information.

• Act as the Main Point of Contact for all compliance related activities
• Lead and/or support client regulatory submissions, client audits and supplier audits. Follow up on committed actions.
• Lead and/or support regulatory inspections.
• Coordinate between departments for responses for audit findings and gap analysis
• Conduct laboratory inspections to include commissioning and/or internal audits as qualified lead auditor / co-auditor
• Review and approve client and supplier quality agreements.
• Review and approve standard operating procedures (SOPs), laboratory / batch records, GMP part numbers, and other quality records.
• Review and approve change control (GCC) records.
• Review and approve study files against regulatory and internal requirements to include protocols, technical specifications, raw data, final reports, and certificates of analysis.
• Review and approve validation files for systems and assays.
• Review and approve deviations / OOS records of varying impact and criticality.
• Conduct trend analysis for deviations and review / approve applicable CAPA records.
• Lead and/or participate in projects as QA subject matter expert and drive discussions to build consensus across the business regarding Quality topics.
• Assist with tracking and trending of BRIQS records (events, CAPA, EC, etc.) for strategic clients, present metrics at meetings and provide support for quality improvements to address trends.
• Escalate significant quality issues impacting strategic clients and highlight at monthly / quarterly quality review board meetings.

Who you are:

• Degree in life sciences or higher related degree
• High science orientation

• 4+ years of experience in Quality Assurance or related field within a GxP environment.
• Shows a desire and motivation to work in Quality and regulated environment.
• Awareness of Biologics regulatory environment and GMP manufacturing topics.
• A proactive approach to all aspects of Quality.

• Acts ethically and ensures quality of own work and that of others.
• Open-minded, flexible and works with agility.
• Takes responsibility for ensuring that turnaround times are met.
• Works with cross-functional teams and builds networks within QA and Operations departments.
• Collaborates with various teams to identify and implement improvements.

• Willing to embrace and implement change on a global scale.
• Customer Orientated - Display High Impact Culture Behavior of Obsessed with Customers and Patients

• Global mindset and to be willing to engage in conference calls at out-of-office hours.

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!

Apply now and become a part of our diverse team!

Job Requisition ID: 267918

Location: Singapore

Career Level: D - Professional (4-9 years)

Working time model: full-time

North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our Candidate Services team at 844-655-6466 from 8:00am to 5:30pm ET Monday through Friday. If you are a resident of a Connecticut or Colorado, you are eligible to receive additional information about the compensation and benefits, which we will provide upon request. You may contact 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday, for assistance.

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Merck Group