Operation Support Specialist

• Develop strategies that align with business imperatives
• Based in Singapore, the regional hub for Asia Pacific (AP) and top-ranked biopharmaceutical company on the Straits Times and Statista\xe2\x80\x99s 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 Manufacturing Operations teams are the people that make our products. We work in the manufacturing plants with a \xe2\x80\x9cSafety First, Quality Always\xe2\x80\x9d mindset striving for continuous improvement. We work in the local plant connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates and finished products. Reporting to the Operations Senior Manager you will be responsible for coordinating and supporting all manufacturing related activities for the Integrated Process Team (IPT).
WHAT YOU WILL DO Responsibilities include, but are not limited to:
Operation Team Start up and Sustainment

• Coordinate technical skills training for shopfloor staff during hands-on training as part of the project.
• Work as serialization lead to coordinate and lead the IPT serialization activities.
• Overall manage the Manufacturing Aids (MA) classification and buying process to commercial batches.

• Process of POs and manage the inventory for non-Bill of Materials, consumables, tools, PPE, gowning, and equipment to support qualification phase and commercial batches.

Safety & Compliance

• Ensure that all assigned daily manufacturing activities are planned and carried out in accordance to Environment, Health and Safety (EHS) requirements.
• Participate in and support the implementation of actions for all incident\xe2\x80\x99s investigations and audits as required.
• Ensure all regulatory permit requirements are met for IPT maintenance activities.
• Promote EHS leadership behaviors and engage employees at all levels on EHS issues.
• Support to meet Profit Plan and cost effectiveness targets.

Enhance and uphold Operations Quality

• Ensure that all assigned tasks related to manufacturing documentation support is in accordance with good manufacturing practices.
• Prepare or update procedures and related documents to ensure compliance with regulatory standards.
• Actively engage in audits and support implementation of agreed follow-up actions.

Operations Excellence

• Prepare and issue necessary documents for production use. These documents are the batch records, manufacturing labels and other essential documentation related for production such as SOPs and Work Instructions (WI).
• Lead the change executions for manufacturing documentation in liaise with other departments in Pharm such as PTO/Process Engineering, Quality and Manufacturing. This includes emergency changes related to the batch documentation when needed.
• Support document revision (SOP, WI, Forms, etc.) when necessary to improve the system of documentation review, issuance, and preparation.
• Maintain proper filing and safe keeping of all relevant manufacturing documents; and retrieve them when required.
• Complete manufacturing batch record review in accordance with cGMP requirements.
• Coordinate SAP shutdown maintenance, support all SAP inventory updates and reversals, release Process Order (PO) and perform Good receipt Delivery Order (DO) into SAP.

Continuous Improvements (CI)

• Utilize MPS tools (8-steps Problem Solving, SMED, 5S, etc) to support execution of continuous improvement projects to increase agility, flow, throughput and reduce cycle time and inventory.
• Support implementation of model area
• Initiate Continuous Improvement (CI) activities in area of responsibility \xe2\x80\x93 Batch document simplification, SOP & WI process review, etc.
• Collect date for APR, Profit planning and management of Tier process.

WHAT YOU MUST HAVE To be successful in this role, you will have:

• Degree or diploma holder in Science, Engineering, or related studies.
• Experience in business process would be an added advantage.
• Good knowledge of applicable Safety and GMP regulations.

WHAT YOU CAN EXPECT

• Opportunity to work in a market giant

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\x94 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\xe2\x80\x99s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace. 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: No relocation VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Shift: Valid Driving License: Hazardous Material(s):
Requisition ID:R227145
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