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Sr. Associate QRM

7.00 to 0.00 Years   Bangalore   04 Jan, 2022
PFIZER LIMITED
Job LocationBangalore
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaSales / BD
EmploymentTypeFull-time

Job Description

QualificationsMust-Have

  • Bachelors Degree
  • 7 years experience
  • Experience in Quality management system.
  • Good understanding of Regulatory Guidelines, Good documentation practices and Good manufacturing practices.
  • Knowledge of current Good Manufacturing Practices and the applicable GxP regulations and standards.
  • Proactive approach and strong critical thinking skills
  • Good communication and interpersonal skills
  • Good working knowledge of Microsoft Excel and Word
Core competency
  • Responsible for taking ownership of the risk management process of manufacturing .
  • Conduct Risk Assessments of Process/ equipment by evaluating risk taking consideration of cross function team and SME view point
  • Determine Risk Control and find possible solutions.
  • Ensure documents are properly maintained, with good documentation practices, for all manufactured distributed products, quality system processes, and applicable solutions.
  • Collaborate with other teams and Coordinate and monitor implementation of risk initiatives.
  • Remain current with industry standards and best practices to promote activities necessary for the evolution of the Pharmaceutical Risk Management System
  • Work with risk owners to ensure that risk management processes are implemented in accordance with agreed policy and strategy
  • Tracking the Risk mitigation Action item and taking ownership to prepare summary of Quality risk assessment after implementation of all action item.
  • Ready to explain QRM as a SME to regulatory inspector
  • Maintain regulatory compliance in accordance with current Good Manufacturing Practices.
  • 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.
  • Will to take additional activity like CAPA evaluation and CCF initiation. coordination with CFT for impact assessment and CCF pre-approval, responsible for closure of CCF.
  • Remain current with industry standards and best practices to promote activities necessary for the evolution of the Pharmaceutical Risk Management System.
Nice-to-Have
  • Willing to lead by example and involves right in, desire to get to root cause, collaborative and active listener
  • Effectively manages stressful situations, able to focus on task at regardless of circumstances and stress induced pressure
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 #LI-PFE,

Keyskills :
risk controlquality systemrisk managementmicrosoft excelrisk assessmentrisk mitigationquality assurancecritical thinkingimpact assessmentquality management

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