Manager Quality Data and Analytics
Pfizer
Full time- 3+ years
- Not Disclosed
- Chennai, India
- Post Date: Apr 24, 2024
- End Date: Jun 24, 2024
- 3+ years
- Not Disclosed
- Chennai, India
- Post Date:Apr 24, 2024
- End Date: Jun 24, 2024
Skills:
- pharma
- telemedicine
- Operations
- product management
- MS Office
- Compliance
- Communication
Job Description:
Responsibilities
- Provide guidance, lead/co-lead projects, manage own time to meet objectives, plan resource requirements for projects across the Department.
- Contribute to Quality Assurance by undertaking a variety of roles or assignments to further develop internal processes and people.
- Assess the operations executed at the supplier for their adherence to regulatory requirements, Quality Agreement requirements and Pfizer expectations.
- Conduct quality reviews and report on results or defined quality analytics to in-country Medical Management, Platform Lines and Regional Medical Quality group, as appropriate.
- Support the development of country quality strategic initiatives based on risk and business needs, in close collaboration with key stakeholders.
- Lead continuous inspection readiness for Quality Assurance.
- Drive effective management of quality issues and Corrective Action Plan (CAPAs) and make decisions that may involve complex quality and technical issues.
- Ensure appropriate networking and sharing of best practices with Corporate Compliance colleagues and with other compliance functions in other Pfizer affiliates or in the market.
- Participate in internal Good Manufacturing Practices {also cGMP} audits and support regulatory inspections or corporate audit activities.
- Perform disposition of clinical trial materials.
- Communicate with and influence internal and external customers across site and department boundaries to ensure compliant and aligned resolution of project related issues and investigations.
- Ensure appropriate internal networking to develop and maintain close and effective business partner relationship with internal colleagues.
Qualifications & Experience
- Applicant must have a High School Diploma (or Equivalent) with 10+ years of relevant experience; OR an Associate's degree with eight years of experience; OR a Bachelor’s degree with at least 5+ years of experience; OR a Master’s degree with more than three years of experience; OR a Ph.D. with 0+ years of experience.
- Pharmaceutical manufacturing/Quality experience
- Current Good Manufacturing Practices experience with compliance issues resulting from cGMP deviations or product defects, regulations as related to vendor management programs and other industry quality systems and processes
- Proactive approach and strong critical thinking skills
- Strong collaboration, relationship management, and interpersonal skills
- Excellent written and verbal communication
- Advanced computer skills in MS Office applications and good knowledge of enterprise systems, such as PDM, Quality Tracking System Trackwise, Documentum platforms
- Experience in Quality Systems in pharmaceutical, medical device, or combination product industry
- Knowledge or exposure to and data science
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