Supply Chain Market and Operations Quality Complaints Hub Associate
2 weeks ago
Supply Chain Market and Operations Quality Complaints Hub Associate page is loaded
Supply Chain Market and Operations Quality Complaints Hub Associate Apply locations Philippines - Makati City time type Full time posted on Posted Today job requisition id Why Patients Need YouEverything 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 AchieveYou will be a member of Pfizer's dedicated and highly effective quality assurance team. You will make sure that the complaints management process is executed compliantly and on a timely manner. Your expertise will help in identifying deviations from established standards and find opportunities in improving the complaints triage process across the region. 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 to 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 ItThe main responsibility of the Supply Chain Market Operations Quality (SCMOQ) Complaints Hub Associate is to provide triage support to the SCMOQ Markets in the APAC region and Hub team at Philippines. Primary Responsibilities includes the following: Complaints triage, Monthly market reports, support internal/external audit management, Risk Management, Trend Analysis, and lead continuous improvement project to drive simplification at the Pfizer Country Offices (PCOs) to ensure compliance with Pfizer Quality Standards and Regulatory Authority expectations under SCMOQ APAC Hub Manager leadership.
- Execute complaints triage of markets in-scope of the SCMOQ Hub
- Lead discussions towards the triage processing and in utilizing the existing Complaints Management System (ex. QTS-CITI, eQMS)
- 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.
- Suggest improvements and conduct continuous improvement activities.
- Independently assess a wide range of Change Control activities to determine potential Quality and Operational Good Manufacturing Practices {also cGMP} impacts.
- Investigate, document Quality Assurance related deviations and escalate issues as appropriate to the Quality Assurance Lead in a timely manner.
- Maintain regulatory compliance in accordance with current Good Manufacturing Practices {part of GxP} practices.
- Provide Quality Review and oversight of site cGXP documentation related to the operation of a vaccine manufacturing facility/laboratory to ensure compliance with global regulatory agencies and Pfizer quality standards.
- Accurately communicate Supply/Operational needs/perspectives as well as Quality Operations (QO) perspectives
- Support the compliance system related activities within the SCMOQ Organization (ex. Point of Contact (POC))
Product Quality Complaints Management
- Evaluate if the report represents a product quality complaint.
- Perform follow up contact with the Intake group and/or the complainant to obtain the necessary and relevant information to process the complaint.
- Intake and Triage of complaints from the local market(s), assign class and criticality to the product complaint and forward them to the appropriate investigating PGS /Contractor Site(s) via the global complaints management system.
- Support the management of the complaint samples, including the tracking of the samples.
- Develop and issue response(s) to the complainant in a timely manner, when required.
- Support answering the queries related to product complaints and the verification/evaluation of product quality complaints trends.
- Support to evaluate the need of a Notification to Management and/or a notification to Regulatory Authorities, in/for the required market(s).
- Support the activities related to the management of the Offline Contractor Site(s) investigations in the global complaints management system (investigations conclusion in the system).
- Sustain additional and complementary alignments and trainings with the involved team(s)/department(s).
- Bachelor's degree in science courses (Pharmacist, Chemist, etc.)
- 3+ years' experience
- Experience in Quality administered systems
- Knowledge of current Good Manufacturing Practices and the applicable GxP regulations and standards
- Proactive approach and strong critical thinking skills
- Must be able to work in a team environment within own team and interdepartmental teams
- Excellent communication and interpersonal skills
- Good working knowledge of Microsoft Excel and Word
- Knowledgeable on the pharmaceutical dosage forms
- Experience working at a pharmaceutical manufacturing site
- Experience of writing and managing deviations
- Experience in Complaints management, production batch record review, Enterprise Resource Planning system, investigation of non-conformance, root cause analysis and change control management
Work Type: Hybrid
Work Location Assignment: Flexible
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Quality Assurance and Control About UsPfizer careers are like no other. In our culture of individual ownership, we believe in our ability to improve future healthcare, and potential to transform millions of lives. We're looking for new talent to join our global community, to unearth new innovative therapies that make the world a healthier place.
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