Merck Gruppe

3 days ago

Singapore Merck Gruppe - MSD Sharp & Dohme Full time

Job Description
THE OPPORTUNITY
Be part of the team that ensures sustainable products meet standard quality and are committed to delivering 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 three consecutive years (2021, 2022, 2023).
Join the
premier biopharmaceutical company
that has been
in Singapore for more than 25 years and in AP for over 60 years.
Our Quality group ensures every single material inside our products is manufactured, processed, tested, packaged, stored, and distributed in alignment 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 delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.
WHAT YOU WILL DO
General Responsibilities
Supports to ensure that all company products are stored, handled, and transported from 3rd Party Providers (3PLs) in accordance with all applicable company and regulatory requirements to meet both internal and external customer demands, the product license, GxP (e.g., Good Distribution Practices (GDPs), Good Manufacturing Practices (GMP)), and contractual and Quality Agreement obligations.
Reports into the APCJ Regional Lead of D&L Quality for general advice and instruction concerning Quality Operations. Receives guidance, management, and directions when necessary. Keeps the APCJ Regional Lead of D&L Quality informed on the status of operations and when challenges, opportunities, and/or issues arise.
Directly works with an experienced team of Quality professionals in both the internal and external network to ensure the compliant and reliable supply of our products to our patients.
Core Responsibilities
Provides support to quality compliance oversight to ensure compliance on topics related to our global Quality Management System (QMS).
Supports to hold wholesale and import license in Singapore.
Provides quality oversight on specific Regional Distribution Centers (RDC) and Distribution & Logistics (D&L) operational activities such as:
Ensures that Quality of RDCs in Singapore is in a state of GxP compliance and that all regulatory requirements regarding Quality and Compliance for Storage and Distribution within company scope are met, including Health Authority interactions on product and distribution Quality matters.
Ensures the quality performance of assigned 3PLs under D&L Quality oversight, e.g., Logistics Service Providers, Thermal Protection System (TPS) Suppliers, TPS Testing labs, Temperature Monitoring Devices suppliers.
Collaborates with internal and external stakeholders to continuously improve the performance of RDCs and transportation lanes by periodically reviewing and addressing internal and external KPIs, CAPA effectiveness, and audit findings.
Leads supplier deviation investigations within storage, transportation, logistics & distribution.
Manages change control requests related to RDC and D&L activities.
Supports Internal and External Shipping Sites on the set-up and management of transportation lanes.
Provides support to internal and external stakeholders related to GDP requirements.
Conducts due diligence and collaborates with suppliers on Quality Agreement negotiation activities.
Supports Company Global Auditing Team to ensure that all required external audits are planned and scheduled.
Supports during qualification, routine, and for-cause audits of suppliers/service providers to ensure compliance with Global and Local company and applicable regulatory requirements.
Reviews and approves CAPA plans for audit observations. Ensures that audit documentation is accurate, complete, and entered in the Audit Tracking System within the required timeframe.
Participates in the launch and approval of thermal protection systems, including quality oversight requirements as per QMS related topics.
WHAT YOU MUST HAVE
Education Requirements
Bachelor’s degree in Chemistry, Pharmacy, Biology, Microbiology, Logistics, Supply Chain Management, Engineering, or similar.
Required Experience and Skills
At least 4 years of relevant work experience in the biotech/pharmaceutical industry (preferably within a Distribution and Logistics environment).
Must be a locally registered pharmacist with a valid registered pharmacist license for Singapore.
Expertise and broad experience in Quality Systems, Quality Assurance, and Quality Control, including solid knowledge of global GDP/GMP, regulatory requirements, and good documentation practices.
Demonstrate strong problem-solving skills, based on science, facts, data, and understanding of the regulatory requirements in complex and evolving environments; must be able to apply sound risk management.
Strong demonstrated interpersonal, communication, and leadership skills to work effectively across cultures on non-routine matters in challenging situations. Able to handle organizational complexity and ambiguity.
Creates an inclusive working environment and is a strong collaborator, including speaking candidly.
Fluent in English.
WHAT YOU CAN EXPECT
Limitless opportunities across various areas in Manufacturing; well-structured career path.
A state-of-the-art facility that delivers solutions to its customers worldwide.
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’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
Employee Status:
Regular
Relocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Hybrid
Shift:
Valid Driving License:
Hazardous Material(s):
Job Posting End Date:
12/28/2024
*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.
Requisition ID:
R324252
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