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Supply Chain Quality Senior Analyst
hace 2 semanas
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 a Senior Analyst, your knowledge and skills will contribute towards the goals and objectives of the team. Your focus and ability to meet team targets will help in completing critical deliverables. Your innovative use of communication tools and techniques will facilitate in explaining difficult issues and establishing consensus between teams.
It is your hard work and focus that will make Pfizer ready to achieve new milestones and help patients across the globe.
How You Will Achieve It- Resolution of Product Quality Compliance Issues- Deviation and Investigation Management Product Complaint handling
- Market Action- Supports any market action in Uruguay and Paraguay according to the local regulations and Pfizer requirements.
Product Quality System- Supports the timely implementation of all applicable Product Quality SOPs (issued by SCQ) within the PCO.- Conducts internal assessments to assess compliance with product quality systems & processes, and to identify improvement opportunities.- Assess new quality system/local regulatory requirements and adjusts/enhances local systems and processes when required.Local Product Disposition- Performs local release of imported products, in compliance with the applicable local regulations and local procedures, prior to distribution/sale within country.- Process returns and supports local actions, in cooperation with logistics and distribution center.
Inspections and Internal Audit- Participates when required in Regulatory Agency and internal Pfizer inspections of Product Quality and Compliance (GMP/GDP) activities at the PCO.- Works with local functions to define an appropriate action plan to address the inspection/audit observation- Tracks the implementation of the identified actions within agreed timeframes
Local Contractor Quality Oversight- Oversees quality operations at contractors, which includes but is not limited to:
o Supports the Contractor Assessment and Approval : supports that all GMP/GDP contractors have been formally assessed and approved
o Deviation Management: evaluates the impact of all significant deviations affecting Safety, identity, strength, purity & quality (SISPQ), generated at the contractor and agrees corrective actions. If necessary, initiates the “Notification to Management” process.
oQuality System Support: visits the contractor to assess quality systems, review quality performance and agree action plans to ensure continuous improvement.- Issue and review Metrics: Periodically assess the overall quality risk associated to the contractor. Act on adverse trends in order to improve contractor quality and compliance performance.- Facilitates the Pfizer Research Quality Assurance global audit process at the contractor. Help to define appropriate action plans for improvement and follow-up and communicate action closures.
Oversight of local Repackaging and Relabeling Operations
Development and Maintenance of Consistent Quality Culture- Change Control- Ensures that a Change Control is initiated for GxP activities under SCQ oversight, when necessary.- Tracks the implementation of the identified actions within agreed timeframes with the involved areas.
**Qualifications**:
Must-Have- Bachelor's Degree- 3+ years' experience in QC and QA areas- 2+ Relevant laboratory experience in pharmaceutical products analysis- Advanced English level- 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
Nice-to-Have- Master's degree and relevant pharmaceutical experience- Willing to lead by example and jump right in, desire to get to root cause, collaborative and active listener- Effectively manag
