Pharma Jobs @ Pfizer | Document Quality Control Analyst Post Vacancy

Pharma Jobs @ Pfizer | Document Quality Control Analyst Post Vacancy

Document Quality Control Analyst Post vacant @ Pfizer. Pfizer 2019 Jobs, Pfizer Document Quality Control Analyst jobs, Pharmaceutical Science jobs  2019. Pfizer hiring M Pharma candidates for a Document Quality Control Analyst vacancy. Interested and eligible candidate can Apply for this post.Check out all the details on the same below:

Job Id: 4728854

Job Title: Document Quality Control Analyst

Work Location: Chennai

Qualifications

Education:

  • A scientific or technical degree is preferred. In general, candidates for this job would have the following levels of education/experience:
  • BS degree (or equivalent).

Experience:

  • Minimum 1-2 years’ experience in clinical, safety and/or regulatory areas in the pharmaceutical/healthcare industry.
  • Experience in quality control and/or quality assurance within the pharmaceutical industry preferred.
  • General knowledge of global safety regulations and guidelines, or equivalent.
  • Demonstrated basic analytical skills and attention to detail.
  • Demonstrated basic oral/written communication and interpersonal skills.
  • Demonstrated organizational/project management skills.
  • Ability to make decisions independently and resolve issues appropriately.
  • Demonstrated computer literacy, particularly in the use and management of relational databases.

Position Purpose

Participates in projects and conducts DQC activities on deliverables ensuring accuracy, internal consistency, uniformity and compliance with regulatory commitments and expectations.

Primary Responsibilities

  • Provides ongoing analysis of data resulting from the quality review of regulatory submission documents/aggregate reports.
  • Collaborates with SER management, epidemiologists, SSRM and others to develop strategies for the creation and collection of metrics data for quality analysis.
  • Participates on project teams, task forces and/or working groups to identify opportunities for strategic alignment of quality and compliance processes and process improvement initiatives.
  • Participates in the investment and strategy decisions related to the technology decisions related to quality.
  • Supports/promotes accuracy, internal consistency, uniformity and compliance with regulatory commitments and expectations.
  • Maintains knowledge of global regulatory requirements relative to pharmacovigilance, regulatory submission requirements, electronic reporting requirements and other relevant regulatory requirements and guidances.
  • Provides support for regulatory inspections, internal audits and/or strategic quality initiatives.
  • Participates in special projects and senior management requests associated with safety compliance.
  • Develops and maintains an understanding of PfAST and case processing activities so as to ensure the accuracy of aggregate reports, ad hoc reports and analyses and safety query responses.
  • Provides mentoring and training for colleagues as necessary, working with Team Leads to provide support across all sites.
  • Compiles and analyzes quality metrics on a routine basis, and periodically reports trends relating to document quality review.
  • Participates in quality activities, setting the standard for enhanced collaboration, delivery of project commitments and customer satisfaction.
  • Plans, designs and participates independently, as appropriate, in the ongoing review of processes related to the collection and analysis of safety information.
  • Participates in the completion of complex tasks by applying technical skills and specialized knowledge to coordinate initial findings, conduct root cause analyses and corrective action planning with customers as necessary.
  • May serve as a quality Subject Matter Expert (SME) on training, knowledge sharing, technology, or specific work processes, providing advice and guidance as appropriate.

Apply Online

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