Site Quality metrics management and Coordination for all Quality Review Meetings at the Vizag site.
Site point of contact for all the Quality metrics management with Pfizer network – Balance Score Card etc.
Data Analysis:
Understand the Quality/ Site objectives – identify the key performance indicators through which the Quality /Site objectives can be measured.
Liaise with internal and external stakeholders who understand the process of defining the metrics and their targets
Analyze large data sets, draw valid inferences, and present them to Management by developing effective visual dashboards that present data that is as close to real-time as possible to support the decision process of continual improvement activities
Coordinating Quality Review Meetings:
Ensure timely reporting of metrics
Ensure S-QRT (Site Quality Review Team) Meetings are scheduled for requirements
Facilitate and coordinate S-QRT and Ad hoc S-QRT meetings
Develop a strategy for improved compliance against the metrics and maintain systems to measure performance against established targets
Assist with Quality improvement recommendations / Process improvements by S-QRT to achieve business targets
Ensure CA/PA (Corrective Actions/Preventive Actions) for the action items indicated through S-QRT are addressed and successfully implemented.
Core Competencies:
Understanding of Pharmaceutical Manufacturing, Packing, Quality Assurance, and Quality Control operations.
Knowledge of Regulations/ Guidance’s, Good Laboratory Practices Good Manufacturing Practices, and ICH guidelines
Statistical tools to track and trend the metrics
Analyze Quality Performance and Process Metrics
Develop strategies for improved compliance against the metrics
Strong interpersonal and communication skills ability to use initiative and drive to achieve results
Must be able to interact effectively at all levels of the company and handle confidential and sensitive information appropriately
Contribute to the completion of complex projects, manage own time to meet agreed targets, and develop plans for work activities on own projects within a team.
Support the realization of the site self-assessment program by conducting internal audits/ walkthroughs, and ensuring the follow-up on corrective/preventive actions.
Support the Inspection Readiness program by coordinating Inspection preparation, conduct, and ensuring the follow-up on regulatory commitments
Deliver training & conducting workshops on different quality management system topics.
Qualifications
Must-Have
Master’s Degree
7+ years of multidisciplinary experience in the Pharma industry
Hands-on experience in trend preparation & review
Experience with preparation and/or facilitation of regulatory inspections
Strong interpersonal skills to provide training
Excellent organizational skills, and ability to handle changing deadlines and responsibilities.
Strong written and verbal communication skills
Strong computer knowledge (MS Office Suite)
Nice-to-Have
Demonstrated ability to learn and master new applications and software
Experienced in auditing with Good Manufacturing Practices (also cGMP) regulated industries
