Specialist, Quality System and Project

1 month ago


Singapur, Singapore West Pharmaceutical Services Full time

Job Summary

:

In this role, you will lead the Technology Transfers from a Quality Assurance and Quality Systems standpoint between the sites and regions with ensuring compliance to Quality Management Systems procedures and protocols. You will drive the execution of ongoing Technology Transfers and provide input to and support Best Practices to ensure product equivalency is achieved. You will determine methods and systems that can continually accelerate Technology Transfers internally and with customers.

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 in the region, as and when needed.

Essential Duties and Responsibilities:

Develop Transfer Strategy together with the Global/Regional NetOp Groups and assist receiving site to complete site readiness processes (QA) before start of transfer production batches. Provide input to and ensure consistency of the Technology Transfer Documents. Work with the Tech Transfer teams to prepare the Transfer documents for approval aligned with agreed RACI: Drive the standardization and streamlining of all Technology Transfer documents. Coordinate with the other Technology Transfer QA Leads to ensure harmonization and standardization of documents. Ensure consistency and standardization of the Summary report incorporating Customer summary reports. Update and train out West Enterprise procedures as needed. Analyze content of the Tech Transfer documents including Risk Assessment data preparation. Advise on changes and mentor and coach Site QA Managers on enhancements and missing data. Ensure that correct Critical Quality Attributes (CQAs) are challenged to prove product equivalency and mitigate identified risks. Drive and embed a preventive action culture via root cause investigation, risk assessments in collaboration with other departments and sites. Support customer approval process. Support and where needed lead, customer technical meetings for specific transfers. Support Quality and / or Customer projects using appropriate project management tools as deemed necessary. This can include internal project such as quality improvement projects as identified via quality data and trending. Support the Customer Notification process including the rules for notification and for customer approval. Supports sites as needed in regard to 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.

Basic Qualifications:  

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.

Preferred Knowledge, Skills and Abilities:

This role requires to attend some 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. Working knowledge in Mandarin language will be an advantage. Proficient in Microsoft applications i.e., Word, Excel, PowerPoint and SAP system. Project management skills Customer Intimacy Collaboration Authority to approve TT documentation as per agreed RACI. 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.

Travel Requirements:

Must be able to travel up to 10% of the time.

Physical and Mental Requirements:

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.

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.



  • Singapur, Singapore TikTok Full time

    About the team This role is part of the Quality Solutions and Implementation team in the Training and Quality pillar of Trust and Safety Operations. Focused on improving quality, the Quality Implementation Specialist will successfully implement quality assessment systems, solutions, and quality improvement projects across our end to end global quality...

  • Quality Specialist

    2 weeks ago


    Singapur, Singapore Baxter Full time

    This is where you save and sustain lives At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients. Baxter's products and therapies are found in...

  • Quality Specialist

    1 month ago


    Singapur, Singapore Baxter Full time

    This is where you save and sustain lives At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients. Baxter's products and therapies are found in...


  • Singapur, Singapore Singtel Full time

    At Singtel, our mission is to Empower Every Generation. We are dedicated to fostering an equitable and forward-thinking work environment where our employees experience a strong sense of Belonging, to make meaningful Impact and Grow both personally and professionally. By joining Singtel, you will be part of a caring, inclusive and diverse workforce that...


  • Singapur, Singapore Best Careers and Opportunities Full time

    JOB LOCATION: SINGAPORE JOB TITLE: TALENT ACQUISITION SPECIALIST Job Description - The Talent Acquisition Specialist will support one of our European Banking client in Singapore. In this role, the successful incumbent will ensure that we are delivering the highest levels of customer satisfaction, and it will involve liaising with client on a day-to-day...

  • Quality Specialist

    2 weeks ago


    Singapur, Singapore IQVIA Full time

    Job Overview The Quality Specialist is responsible to carry out and adopt the global Quality Plan according to the specific needs defined by the scope of the assignment, to assist the assigned business line staff in improving compliance with relevant International Conference on Harmonization (ICH), Good Clinical Practice (GCP), Standard Operating...


  • Singapur, Singapore Best Careers and Opportunities Full time

    JOB LOCATION: SINGAPORE JOB TITLE: TALENT ACQUISITION SPECIALIST Job Description - The Talent Acquisition Specialist will support one of our European Banking client in Singapore. In this role, the successful incumbent will ensure that we are delivering the highest levels of customer satisfaction, and it will involve liaising with client on a day-to-day...

  • Quality Specialist

    1 month ago


    Singapur, Singapore Flintex Consulting Pte Ltd Full time

    Job DescriptionPosition Summary ResponsibilitiesPrimary Responsibilities• Inspect, test and sample materials or assembled parts or products for defects and deviations from specifications• Observe and monitor production operations and equipment to ensure conformance to specifications and make or order necessary process or assembly adjustments• Discuss...


  • Singapur, Singapore Best Careers and Opportunities Full time

    JOB LOCATION: SINGAPORE JOB TITLE: QUALITY ASSURANCE ANALYST Job Description: Role Purpose: The Quality Specialist will be primarily responsible for performing Quality transaction monitoring across the SMB Programs for internal stakeholders as well as external vendors in APAC. Ideal candidates will need to be proficient in both Customer Service and Sales...


  • Singapur, Singapore Best Careers and Opportunities Full time

    JOB LOCATION: SINGAPORE JOB TITLE: QUALITY ASSURANCE ANALYST Job Description: Role Purpose: The Quality Specialist will be primarily responsible for performing Quality transaction monitoring across the SMB Programs for internal stakeholders as well as external vendors in APAC. Ideal candidates will need to be proficient in both Customer Service and Sales...


  • Singapur, Singapore ST Engineering Full time

    Title: Senior/ System Specialist Job ID: Location: ST Engineering Hub, SG Description: ST Engineering is a global technology, defence, and engineering group with offices across Asia, Europe, the Middle East, and the U.S., serving customers in more than countries. The Group uses technology and innovation to solve real-world problems and improve...


  • Singapur, Singapore Boeing Full time

    Job Description Qualifications: Position Overview: Boeing Commercial Airplanes is looking for an Supplier Quality Specialist in Singapore to assists with audits and assessments of supplier's systems, processes and products. Documents audit and assessment results. Inspects or verifies less complex products for compliance. Monitors supplier quality...


  • Singapur, Singapore EDMI Limited Full time

    Job Title: Quality System Engineer (partially supporting Subcon)Job Level: EngineerObjectivesSupport the QMS manager in the maintenance & continuous improvement of all the Management System (ISO9001, ISO14001, ISO45001, ISO27001, ISO17025, MID-D, LNE, QC80000, IECEx80079) of EDMI group including procedures and processes documentations. Co-ordinate and ensure...


  • Singapur, Singapore EDMI Limited Full time

    Job Title: Quality System Engineer (partially supporting Subcon)Job Level: EngineerObjectivesSupport the QMS manager in the maintenance & continuous improvement of all the Management System (ISO9001, ISO14001, ISO45001, ISO27001, ISO17025, MID-D, LNE, QC80000, IECEx80079) of EDMI group including procedures and processes documentations. Co-ordinate and ensure...

  • Quality Specialist

    2 weeks ago


    Singapur, Singapore West Pharmaceutical Services Full time

    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...

  • Quality Specialist

    4 weeks ago


    Singapur, Singapore West Pharmaceutical Services Full time

    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...


  • Singapur, Singapore Boeing Full time

    Job Description Qualifications: Position Overview: Boeing Commercial Airplanes is looking for an Supplier Quality Specialist in Singapore to assists with audits and assessments of supplier's systems, processes and products. Documents audit and assessment results. Inspects or verifies less complex products for compliance. Monitors supplier...


  • Singapur, Singapore TikTok Full time

    About the team This role is part of the Quality Solutions and Implementation team in the Training and Quality pillar of Trust and Safety Operations. Focused on improving quality, the Quality Implementation Specialist will successfully implement quality assessment systems, solutions, and quality improvement projects across our end to end global quality...

  • Project Specialist

    4 weeks ago


    Singapur, Singapore Maker Lab Full time

    Grounded in a talent-centric mindset, Maker Lab is a marketing agency designed to build decentralised technology-led agency teams, rooted in collaboration with clients from the ground up. Maker Lab’s cross-functional teams of multidisciplinary specialists are embedded into client teams across digital marketing competencies — from measurement & analytics...

  • Project Specialist

    2 weeks ago


    Singapur, Singapore Maker Lab Full time

    Grounded in a talent-centric mindset, Maker Lab is a marketing agency designed to build decentralised technology-led agency teams, rooted in collaboration with clients from the ground up. Maker Lab's cross-functional teams of multidisciplinary specialists are embedded into client teams across digital marketing competencies — from measurement & analytics to...