Why Patients Need You

Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.

What You Will Achieve

The incumbent is a member of the Quality Assurance team. Under the supervision of the Senior QA Manager / Lead QA Specialist, the incumbent will be responsible for the following:

• Provide Quality Assurance oversight to site operations (primarily Production, Quality Control, Warehouse, Engineering) to ensure products produced are in compliance with Pfizer Quality Standards (PQS) and ICH guidelines.
• Work with supply chain and downstream / drug product sites to ensure timely delivery of quality products.
• Support regulatory team to file products and address regulatory queries in an accurate and timely manner.
• Understand regulatory expectations and support site inspection readiness.
• Drive quality culture and promote GMP compliant behaviours at the site.
• Drive improvement of quality systems in collaboration with cross functional teams.
• Contribute to achieve our vision of being best in class manufacturing site, producing highest quality products in the safest way.
• Deploy and use Imex "way of working" for day to day operations, problem solving, escalation and continuous improvements.

How You Will Achieve It

Responsibilities:

• Review and approve GMP documentation (e.g. GMP forms, protocols, reports, cleaning records, batch records, work instructions) to ensure their compliance with PQS.
• Disposition intermediates and active pharmaceutical ingredients (API).
• Support control and issuance of GMP controlled documentation.
• Coordinate with cross-functional team to prepare Annual Product Record Reviews, discuss trends and atypical observations and recommend improvement actions.
• Participate in process risk assessments (e.g. FMEA) as part of new product introductions and/or process changes.
• Support logistics for internal and external GMP inspections.
• Maintain inspection readiness and support inspections from regulatory agencies and customers. Actively participate in GMP walk downs to ensure site operation and facility maintained in inspection ready state and adhere to site procedures and PQS.
• Participate in gap analysis of site procedures against PQS and propose required actions to address identified gaps and mitigate risks.
• Maintain current quality tracking systems and quality metrics to proactively identify trends and atypical observations.
• Handle investigations according to site procedures (as required).
• Support the maintenance of validated state of GMP systems and processes.
• Uphold Pfizer's code of conduct and values.
• Play an active and impactful role in Tier processes by updating performance against metrics, highlighting & resolving issues, with appropriate escalations.
• Collaborate with cross-functional teams to drive flawless execution.
• Actively participate in Safety initiatives, and perform investigation related to EHS (as needed).

Job Related Requirements:

• Demonstrate ability to act independently to resolve issues, with appropriate escalations (as required).
• Strong verbal, written communication and presentation skills.
• Demonstrated ability to perform in a team.
• Possess a can-do / pride to succeed attitude.
• Embrace the use of digital technology to scale and speed up every form of interaction and action.

Qualifications

• Degree in Chemistry, Microbiology, Engineering or other Science related discipline.

Work Location Assignment: On Premise

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Job Summary

We are seeking a Test Specialist to join our client's Customer Digital team to support the Test Plan and Test Execution as well as to gather user insights, ideas to streamline into system design that balances customer needs, business constraints & technological challenges.

Mandatory Skill-set

• Degree in Design, Communications, Marketing, Statistics, Business and Information Technology;
• Has 3 years of experience in conducting A/B testing and multivariate testing using Website Optimisation tools;
• Familiarity with testing and insights tools (AB tasty, Optimizely, Adobe Target, VWO);
• Strong interest in the area of web and user application design ( UI / UX );
• Experience with HTML, CSS, and JavaScript for making changes during testing;
• Experience leverage data-driven insights to enhance user experience and website performance;
• Experience with user interface design patterns and standard User-Centered Design methodologies;
• Familiar with the latest interface design and user experience trends and best practices;
• Strong business communications skills, strong verbal & written presentation & documentation skills.

Desired Skill-set

• Certifications in VWO.

Responsibilities

• Involved in gathering, developing and implementing A/B tests, multivariate tests using VWO (Visual Website Optimizer) to improve website functionality and user engagement;
• Work closely with cross-functional teams, product owners and project team to understand business objectives and translate them into test hypotheses;
• Involved in the Test Planning and Test Execution and drive insights to enhance website performance;
• Identify areas of improvement on the website through ongoing analysis, feedback loops, and industry best practices;
• Collaborate with UX/UI designers and content owners to design, develop and optimize wireframes, user journeys based on the various test outcomes;
• Involve in identifying and troubleshooting UX problems;
• Share regular reports on test performance, providing clear and concise information on key metrics and insights;
• Ensure consistent style guide throughout the sites with appropriate design changes in accordance to corporate branding.

Should you be interested in this career opportunity, please send in your updated resume to [email protected] at the earliest.

When you apply, you voluntarily consent to the disclosure, collection and use of your personal data for employment/recruitment and related purposes in accordance with the SCIENTE Group Privacy Policy, a copy of which is published at SCIENTE’s website (https://www.sciente.com/privacy-policy).

Confidentiality is assured, and only shortlisted candidates will be notified for interviews.

EA Licence No. 07C5639

Why Patients Need You

Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients.  Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.

What You Will Achieve

You will be a member of Pfizer’s dedicated and highly effective quality assurance team. You will evaluate and review Pfizer’s clinical and commercial batches of drugs. You will make sure that product and process documents match the specifications based on established sampling and statistical process control procedures. Your expertise will help in identifying deviations from established standards, in the manufacturing and packaging of products. In the relevant cases you will approve investigations and change control activities to ensure compliance with configuration management policies.

As an associate, your focus on the job will contribute in achieving project tasks and goals. Through your domain knowledge and commitment, you will create a collaborative teaming environment for your colleagues.

It is your hard work and commitment that will make Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It

• Contribute to the completion of projects, manage own time to meet agreed targets and develop plans for work activities on own projects within a team.
• Create, review and approve Good Manufacturing Practices {also cGMP} validation documentation.
• Review and approve Manufacturing and Packaging records to ensure that the information and documentation conforms to Pfizer policy and cGMP's.
• Ensure that all documents received in the batch release area reviewed for completeness and accuracy.
• Provide Real Time Quality impact assessments and decisions on product and medical device issues, independently.
• Maintain inspection readiness, support inspections from regulatory agencies & customers and improve quality assurance systems.
• Assist and support the manufacturing/packaging staff in detecting and solving compliance errors in real time during manufacturing and packaging operations.
• Help to define appropriate action plans for improvement and follow-up and communicate action closures.

Qualifications

Must-Have

• Bachelor's Degree
• Experience in Quality administered systems
• Ability to work in a team environment within own team and interdepartmental teams
• Effective written and oral communication skills

Nice-to-Have

• Experience at a manufacturing site
• Experience of writing and managing deviations
• Experience in production batch record review, Enterprise Resource Planning system, investigation of non-conformance, root cause analysis and change control management

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

As part of the Micro/EM Team, you will be responsible but not limited to the following:

• Performance of testing of EM / product stream samples to meet product release timelines and in accordance with cGMP regulations and Roche/Genentech standards.
• Support manufacturing operations by timely completion of testing and disposition.
• Continuous improvement of processes and technology, in collaboration with ASAT, to drive right first time and efficiencies.
• Qualification and validation of test methods.
• Supporting investigations of microbial contamination in production processes, classified environments, and critical utility systems.
• Ensuring test methods and data are generated in a compliant manner following cGMPs.

Key Responsibilities

Technical and Functional:

• Testing and review of routine and non-routine environmental, raw material, product related samples in accordance to the Standard Operating Procedures (SOP) and Test Methods (TM).
• Perform EM which includes HVAC / BSC / HLFH / VLFH sampling, fingertips monitoring, compressed gases and water / clean steam sampling in accordance to cGMP procedures when required.
• Documentation and review of results in the Laboratory Information Management System (LIMS) and/or documents in accordance with cGMP Procedures.
• Prepare EM reports / trend graph for product lot release and trend data analysis.
• Review routine data and logbooks.
• General lab support including housekeeping, equipment maintenance, document archival, maintaining logbooks and inventory of lab supplies, etc.
• Problem solving of testing related issues as well as troubleshooting of equipment.
• Author and/or update existing SOPs, Forms, OJTs and TMs as needed.
• Initiate discrepancy record, perform discrepancy assessment and identify corrective actions where necessary.
• Train other analysts on methods and/or SOP.
• Responsible for ensuring that all training required to support / perform GMP activities are completed timely.
• Participate in internal / external audits and regulatory inspections.
• Raise work notification, g2g shopping cart for purchase of consumables / reagent / media for Lab use. Follow up on the planned receipt, Delivery orders, invoices when required.
• Understanding of basic microbiological principles (bioburden, LAL, plating and counting techniques, etc) and execution of intermediate techniques (DET, AET).
• Participate in project, validation and process improvement works.
• Perform equipment qualification / maintenance, liaise with external / contract lab / vendor.
• Contribute to the continuous improvement of laboratory procedures and processes to ensure compliance to GMPs.
• Provide forecast for consumables / reagent / media used and facilitate in budgeting and financial planning.
• Perform sample receipt and storage of QC samples.
• Manage the life-cycle process for retain and reserve/reference samples.
• Manage and prepare the shipment of samples to Receiving labs.

Leadership:

• Work co-operatively with the Head of Micro/EM and QC Supervisor to create an environment of strong team spirit, timely and effective communications. Strive towards team’s objectives/goals, takes the initiative and proactively turn ideas into action – to make things happen.
• Engage in proactive measures to promote a positive safety culture while ensuring all applicable Safety, Health and Environment requirements are fulfilled in alignment with corporate policy and local legal requirements.
• Embody PT behaviors, lean principles and methods while fostering a continuous improvement mindset throughout the organization by encouraging experimentation and learning.
• A team player and the willingness to cover other colleagues in continued support of the Micro/EM operations.

Safety, Health & Environment:

• Comply with all RSTO’s Safety, Health & Environmental (SHE) requirements, never put oneself and others at safety & health risks, and report any workplace accidents, near misses and hazards as soon as practicable.
• Observe all RSTO’s site security measures at all times, and report any suspicious characters/objects & damaged security mechanisms to Site Security immediately.

Lean Production System:

• Embody PT Lean Production System (LPS), while demonstrating a continuous improvement mindset and behaviors through the use and application of LPS tools for continuous improvement initiatives.

​

Qualifications

• Degree in Microbiology, Biology, Biochemistry or any Life Sciences discipline or equivalent
• 1-3 years of related working experience for degree holders or equivalent holders with combination of education and relative work experience
• Related working experience in a biotech or pharmaceutical operating environment is a plus
• Knowledge / Skills / Competencies:

−Knowledge of cGMP relevant to the pharmaceutical industry

−Knowledge of laboratory safety procedures

−Able to determine when to escalate issue

−Ability to organize and plan effectively

−Good team player

−Demonstrate excellent verbal and written communication skills in English

The Quality Assurance Specialist is responsible to:
- Maintain and ensure effectiveness of the Quality Management System in Singapore,
- Perform product complaints handling for Singapore,
- Perform Adverse Events reporting to local regulatory authorities of Singapore,
- Perform Field Safety Corrective Actions and reporting for Singapore.

Responsibilities:

• Quality Assurance for all aspects of the Quality Management System (QMS) of Singapore Distribution Centre (DC), including maintenance, continued compliance, and certification.
• Ensure quality and regulatory compliance to relevant applicable standards such as GDPMDS (Singapore)

• Be responsible for operational quality matters including product hold in Singapore.

• Act as the Complaints Handling unit for Singapore.
• Conduct training of staff in QMS to ensure relevant staff are trained to the latest revision of procedures.

• To perform assessment and adverse event reporting to local authorities of Singapore.
• Execute Field Safety Corrective Actions (FSCA) in Singapore, including reporting to local authorities.

• Manage outsourced activities to ensure vendors meet the Cook Medical's quality standards.

• Coordinate or investigate CAPA to ensure nonconformances are addressed effectively.

• Schedule and perform internal audits. Host or support external audits.

• Perform trending and produce metrics for DC performance, measuring against key performance indicators.

• Maintain up-to-date knowledge and compliance with Global policies and procedures and to implement locally.

• Participate in global projects and meetings if applicable.

• Act as the local contact person for Data Protection facilitation.

• Perform other tasks assigned by Manager.

• Have a sound understanding of, and comply with, the COOK Code of Conduct and Company Compliance requirements.

Requirements:

• At least 3 years working experience as quality assurance in the medical device field.

• Degree in Science, Engineering or other related discipline.
• Experience in adverse event assessment and reporting for Singapore.
• Experience in Field Safety Corrective Action execution and reporting for Singapore.
• Experience in multinational medical device company preferred.

• Excellent communication and interpersonal skills, able to work with people from different levels internally and externally.
• Excellent time management and organizational skills. Able to perform duties with limited supervision and meet deadline.

• Fluent in English (both spoken and written).
• Skilled in document management.
• High level of computer skills including Microsoft Office.
• Multi-tasks and able to prioritize the job tasks, depending on the urgency.
• Positive attitude, be good team player and attend to details.

Job Description:

Spare Parts

· To deliver spare parts service to internal and external customers within the Service level agreement (SLA)

· To monitor processes & procedures for service parts operations such as advanced / standard replacement, repair & return, analysis and return process

· To monitor and make sure all the loaned parts to customers and engineers were return according to procedure

· Involve in customs, freight matters e.g. freight bill negotiation / verification, reviewing freight rate and shipping company for all the international inbound / outbound shipment

· To monitor and manage the performance of outsources / non outsourced service logistics operations to ensure service is delivered within KPI

· Guarantee service parts stock data accurate, reduce the company assets safety risk and standardize the service parts management operations

· Achieve KPI set by Management e.g. On time service delivery, Inventory Turnover Rate and maintain spare part stock accuracy.

· Monthly reporting e.g. inventory, borrowing, repair & return, analysis reports

Quality & Operation

· To audit quality of safety security domain and improve network change quality

· Communicate and audit engineers to ensure engineers comply with the network change process and KCP as well as D&S Cyber Security Management Requirements

Job Requirement:

· Diploma or bachelor degree in warehouse / inventory management for spare part position

· Min. 1 year relevant experience in warehouse / inventory management is preferred

· Excellent organisational skills

· Good interpersonal and communication skills, able to interact with internal / external customers

· Need to be able to travel within Singapore to different offices / warehouse

· Good command of English and Chinese is required to be able to communicate with various speaking business associates

· To be able to work independently and make skillful decisions