- Work closely with the program team to support the global/regional China DMF-related activities from pre-registration until post-registration. Manage Spec Justification and relevant document to the Master Specifications. Coordinate sampling process with Lab and site QA to ensure testing and release are completed on time. Work closely with team to initiate process of creating/updating item code as requested by customers. Provide historical analytical data to support capability studies for review of compliance to China requirements. Review data statistically and provide justifications for reduced testing as required. Writing technical reports as required to support China DMF submissions. Writing / updating existing QA documents related to China DMF project. Support necessary initiatives to continuously improve on the workflow and systems. Support, as required, customer technical/quality meetings associated with relevant China DMF submissions.
- Supports sites as needed regarding customer audits / complaint handling / site specific project as deemed required by the line manager.
- Interface with other West sites with respect to sharing of best practices and harmonization / standardization of West Procedures and practices.
- Responsibility for reporting/generating of quality data on a monthly, quarterly and or annual basis both internally and in support of customer meetings.
- Lead / support other Quality Improvements projects as directed by the line Manager.
- Support other QA functions in the plants where necessary.
- Other duties as assigned by manager.
- Education or Equivalent Experience: bachelor's in chemistry, Chemical Engineering, or other Science based program.
- Working knowledge of ISO 15378 and ISO 9001 or equivalent quality standards and good knowledge of GMP.
- Desirable: Six Sigma qualification e.g., green / black belt.
- Min. 3 years' experience in a GMP working environment.
- This role requires to attend evening calls with global / regional team.
- Effective communication and interpersonal skills.
- Ability to report technical details in a simple and concise manner.
- Good written and verbal communication skills.
- Proficient in Microsoft applications i.e., Word, Excel, PowerPoint and SAP system.
- Project management skills
- Customer Intimacy
- Collaboration
- Relationship building and contributing to team success.
- Strong analytical, communication, and interpersonal skills.
- Ability to work in a matrix environment.
- Must be able to travel as requested by the position.
- Able to be aware of all relevant standard operating procedures as per Company policy as they are related to the position covered by this Job Description
- Able to always comply with the company's safety policy.
- Able to always comply with the company's quality policy.
- Must be able to travel up to 10% of the time.
- Physical Requirements: Sedentary.
- Mental requirements: communication, quick decision making, interpreting data, reading or writing, public speaking, e.g., Must be able to express or exchange ideas with employees; Must be able to understand direction and adhere to established procedures.
-
Quality Specialist
6 days ago
RECRUITPEDIA PTE. LTD. Singapore**Our client is a MNC, one of the leading players in the F&B Manufacturing. Due to business needs, they are now recruiting a Quality Specialist or Manager to be part of their Quality team for ongoing transformation projects. They are located in the North - easily accessible.** · ...
-
Quality Specialist
4 days ago
RECRUITPEDIA PTE. LTD. Singapore**Our client is a MNC, one of the leading players in the F&B Manufacturing. Due to business needs, they are now recruiting a Quality Specialist to be part of their Quality team for ongoing transformation projects. They are located in the North - easily accessible.** · **The Dutie ...
-
Quality Specialist
9 hours ago
Spring Professional (Singapore) Pte Ltd Singapore**Quality Specialist (APAC)** · Our client is one of the leading listed IVD MNC with a strong presence in APAC. · **Responsibilities**: · - Maintain QMS and EMS to meet requirements of ISO 13485 and ISO 9001. · - Perform regional internal audits, external audits, and management r ...
-
Quality Specialist
4 days ago
Experis Singapore**Quality Specialist** · **Responsibilities**: · - Execute quality assessments as per the framework across the Product & CX Operations space · - Monitor and be responsible for all quality assurance metrics across assigned regions/products · - Include/updated key workflow changes, ...
-
Quality Specialist
3 days ago
Kone SingaporeDid you know KONE moves over one billion people every day. We employ over 60,000 driven professionals in over 60 countries worldwide joined together by a shared vision. As a global leader in the elevator and escalator industry, it is our mission to improve the flow of urban life. ...
-
Quality Specialist
1 week ago
WWT APJ-SINGAPORE PTE. LTD. Singapore**About WWT**: · World Wide Technology (WWT) is a global technology integrator and supply chain solutions provider. Based in St. Louis, WWT works closely with industry leaders such as Cisco, HPE, Dell EMC, NetApp, VMware, Intel, AWS, Microsoft, and F5, focusing on three market se ...
-
Quality Specialist
4 days ago
amaris SingaporeJob description · About the job · Support equipment, critical reagents, and method transfer-related qualification activities. · Set up and maintain cell lines used for bioassays and support methods. · Participate in bioassay/QC-related routine and non-routine activities according ...
-
Quality Specialist
4 days ago
Amaris Consulting Singapore**Who are we? **:**Amaris Consulting** is an independent technology consulting firm providing guidance and solutions to businesses. With more than 1,000 clients across the globe, we have been rolling out solutions in major projects for over a decade - this is made possible by an ...
-
Quality Control Specialist
1 week ago
MR POPIAH PTE. LTD. Singapore**Job Overview**: · We are seeking a highly motivated and detail-oriented Quality Control Specialist to join our food production team. As the QC Specialist, you will play a crucial role in ensuring the consistent quality and safety of our popiah products throughout the production ...
-
Quality Assurance Specialist
2 days ago
BIOSYNGEN PTE. LTD. SingaporeThe Quality Assurance Specialist implements validation processes to identify deviations and potential risks in the CMC, QC and related processes. You are responsible for first-line verification of quality standards in the organisation and supports the product release and registra ...
-
Data Quality Specialist
9 hours ago
TANGSPAC CONSULTING PTE LTD SingaporeOur client, financial institution with large Data team in Singapore is looking to hire Collibra Data Quality (CDQ) Specialist (expert in establishing DQ rules/writing SQL queries in CDQ) · **Scope of work**: · - Identification of Data Quality rules required from the business - ha ...
-
Quality Operations Specialist
3 days ago
AbbVie Singapore**Company Description** · **Job Description** Purpose** · Quality Operations Specialist must always assist site management to oversight the quality system execution on the manufacturing and production areas. Incumbent is required to observe, document, discuss, and report quality ...
-
Regional Quality Specialist
1 day ago
Kerry Consulting Singapore**Description**: · Our client is a global food and nutrition MNC and am hiring for a Quality Specialist to be based in Singapore. · **Responsibilities** · This role reports to the Quality Assurance Manager and will be responsible for managing food safety and quality matters for c ...
-
Quality Operations Specialist
4 days ago
NUSANTARA PRIME CONSULTING PTE. LTD. Singapore**Responsibilities: · Quality Operations Specialist must assist site management to oversight the quality system execution on the manufacturing and production areas at all times. · The personnel are required to observe, document, discuss, and report quality adverse events related ...
-
Quality Operations Specialist
4 days ago
NUSANTARA PRIME CONSULTING PTE LTD SingaporeQuality Operations Specialists must assist site management to oversight the quality system execution on the manufacturing and production areas at all times. The personnel are required to observe, document, discuss, and report quality adverse events related to the manufacturing of ...
-
Quality Systems Specialist
3 days ago
INTERNATIONAL WORKPLACE CONSULTING PTE. LTD. SingaporeOur MNC client is hiring They are a global leader in the discovery, development and safe manufacture of new drug therapies. · The vacancy - **Quality Systems Specialist **is an important role in the compliance and quality department. · You must be someone who is able to regularly ...
-
Quality Assurance Specialist
1 day ago
Merck KGaA SingaporeWork 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 Electro ...
-
Quality Assurance Specialist
3 days ago
FRIESLANDCAMPINA AMEA PTE. LTD. SingaporeThe QA CSC specialist is part of the Customer Supply Chain Professional team. The mission of the group is to be the trusted conscience that leads & supports in quality, food safety & compliance. QA brings quality awareness in the hearts & minds of our people and contributes to Su ...
-
Quality Control Specialist
2 days ago
J&T EXPRESS SINGAPORE PTE. LTD. SingaporeJ&T Express is a technology-driven eCommerce enabler for brands and sellers to embark and scale their eCommerce businesses. We converge technology and services to power the next generation of eCommerce businesses. · We are passionate, enthusiastic, and open-minded in providing th ...
-
Quality Systems Specialist
3 days ago
Medtronic Singapore**Careers That Change Lives · **Our Global Quality Strategy is rooted in the Medtronic Mission and our Quality Policy. Being a 'trusted partner' means always putting patient safety first, upholding product quality, and maintaining the highest ethical standards in our business rel ...
Quality Specialist - Singapur, Singapore - West Pharmaceutical Services
Description
Job Summary
:In this role the job holder will support the business to reach and keep compliance with China regulatory requirements, provide training as needed to ensure on going compliance to the China regulatory requirements.
You will implement, harmonize, and standardize elements of West quality systems as required by West Corporate QA. You will also support other quality related programs, as and when needed.
Essential Duties and Responsibilities:
Basic Qualifications:
Preferred Knowledge, Skills and Abilities:
Travel Requirements:
Physical and Mental Requirements:
West embraces diversity and equality of opportunity. We foster an environment where all individuals are safe, treated fairly, valued and respected. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, disability status or other applicable legally protected characteristics. Where permitted by law, employment with West Pharmaceutical Services, Inc. or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of post-offer background screening and/or drug screening.
