Sr Quality Associate | Pfizer | Chennai

Job Description

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 Associate, 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 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.

Role & Responsibilities:

• 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 GDP performance activities and quality metrics to determine potential Quality and Operational impacts.
• Investigate, and document Quality Assurance related deviations, supporting investigations where distribution quality is impacted
• Maintain regulatory compliance in accordance with current Good Distribution Practices {part of GxP} practices.
• Provide Quality Review and oversight of Distribution Quality vendors, working closely with Vendor Quality Managers to ensure a proactive approach to vendor performance concerns and supporting quality reviews

Quality Operations:

Incident Records Management:

• Manage in-transit transportation incidents that occur within Intercompany operations processes by leading incident triaging including Cross Dock Incidents
• Ensure and follow up on incident management records for data quality and compliance with reporting procedures, Check for complaint accuracy and content, and correct information to process the complaint.
• Ensure the timely follow-up and closure of records in QTS LC / eQMS
• Support the maintenance of SOP/ WI related to incident management
• Supporting administrative tasks in the Incident Management system ensuring that records are managed within required timeframes
• Ensure oversight of SCM open records, working closely with TCL, and Supporting closing Controlant SCM shipments where necessary
• Collaborate with relevant stakeholders for incident management record deliverables eg Market Quality, LSCA, LDO

Continuous Improvement

• Ensure tracking and continuous improvement of incident management records ( QTS LC / eQMS ) working in close collaboration with LSCA/TCL on incident metric overview including:
  • preparation of metrics for T3 SQRT or  ORMs as required
  • preparation of metrics to support the vendor management quality oversight (Quality Review meetings)
  • CI / Trending trends analysis process ( Supported by/in collaboration with the relevant Vendor Quality Manager (VQM)), identification of trends (events/deviations), initiation of the investigation, participation in investigation meetings, review of the trend Analysis report,
  • Complete effectiveness check on trend investigations and CAPA
  • supporting Market Quality forums with technical data and metrics
  • Support the Transport Quality team with CI IMEX
  • Supporting CI projects that utilize incident data trends to reduce lane risk, increase packaging requirements

Quality System support:

• Collaborate with internal and external stakeholders to resolve quality issues and ensure compliance to GxP standards
• Support inspection readiness for BOH inspections and external vendor audits
• Support and participate in projects relevant to the team

Qualifications

Must-Have

• Bachelor’s Degree
• 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

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 manages stressful situations, able to focus on tasks at regardless of circumstances and stress-induced pressure

Department: Quality Assurance and Control