THE OPPORTUNITY:
Our Quality teams 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 the globe.
This position is responsible to support initiatives to optimize laboratory systems, improve efficiency and productivity in quality laboratories.
WHAT WILL YOU DO:
Main responsibilities include:
Maintains laboratory quality systems in accordance with cGMP and our quality guidelines.
Leads lab system improvement and harmonization projects throughout all Quality Laboratories.
Leads and supports initiatives in driving technology-enabled laboratory by developing technical and innovative solution to improve work efficiencies and productivities in quality laboratories.
Maintains Laboratory Tier 4 matrix and Quality Risk Management risk register. Assists Lab COE manager to drive scorecard improvements.
Develops and provides justifications for laboratory related capital projects.
Acts as the subject matter expert and Quality Management System topic lead for the laboratory systems, engages directly in internal and external quality/regulatory audits and in the development and execution of any remediation actions that may be required.
Provides technical coaching and guidance to Lab COE, senior/specialists and laboratory staff.
Provide system administration and technical support/coordination of laboratory systems, including but not limited to LIMS, Empower, LabX, computerized and non-computerized lab equipment as well as systems maintenance related activities.
Develop change control for lab equipment qualification, system development life cycle (SDLC) of computerized lab equipment and systems.
Responsible for maintenance, improvement and harmonization of laboratory systems and procedures.
Ensures the above activities are performed in accordance with cGMP, quality guidelines and all applicable regulatory guidelines.
WHAT YOU MUST HAVE
Degree / Diploma in Science.
B.Sc in Science, preferably Chemistry or Chemical Engineering with minimum 7 years\xe2\x80\x99 experience in the pharmaceutical industries, or Diploma in Chemistry with minimum 8 years\xe2\x80\x99 experience in the relevant industries/labs.
Continuous improvement mindset.
Good knowledge and understanding of GMP.
Good knowledge and application of Lean.
Demonstrates capability in the application of appropriate troubleshooting, root cause analysis and problem solving techniques.
Demonstrates the ability to develop and promote an environment that nurtures creativity and improvement of current ways of doing things.
Demonstrates active skill in challenging the status quo, offering practical alternatives.
Demonstrates the ability to actively seek opportunities for improving department processes and increasing efficiency.
Leadership, Professional and Functional Competencies:
Previous On the Job Training (OJT) / Coaching skills is preferred
Good understanding of Safety and cGMP practices
Computer Literacy
The experience in operating laboratory equipment and lab computer systems is very desirable
Good oral and written communication and facilitation skills
Other Personal Attributes: Self-motivated, Independent, Team Player, Highly Approachable, Meticulous
WHAT YOU CAN EXPECT
Limitless opportunities across various areas in Manufacturing; well-structured career path
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\xe2\x80\x99s committed to delivering a high quality, reliable supply to customers and patients on time, every time.
Who we are \xe2\x80\xa6
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 \xe2\x80\xa6
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\xe2\x80\x94and start making your impact today.
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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.
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