Associate Manager – Quality Compliance

11 hours ago

Vizag, Andhra Pradesh, India Pfizer Full time ₹ 12,00,000 - ₹ 24,00,000 per year

Use Your Power for Purpose

Every day, Pfizer's unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is both flexible and innovative, always putting the patient first. Your expertise will be vital in implementing documentation systems, proposing change control processes, and coordinating the review of procedures and forms. Your dedication and hard work have a significant impact on countless lives.

What You Will Achieve

  • Supports seamless management of global Quality Tracking System (gQTS) and electronic Quality Management System (eQMS) activities, ensuring consistent quality compliance at the Vizag site.

  • Drives thorough investigations into user errors and system functioning issues in coordination with the global technical support teams.
  • Strengthens process reliability and helps sustain key quality indicators, by proactively supporting users to ensure on-time processing of records, also support in investigations related to system performance.
  • Coordinating with global support team to track the system outages (planned & unplanned) and supporting site by implementing BCP to ensure process compliance.
  • Supporting Internal Audits & External audits/ inspections/ assessments to demonstrate the system overview and sharing the data exports/ records as per audit requests.
  • Acts as the site's subject matter expert and business administrator for quality systems, facilitating training, managing user access, and collaborating with cross-functional teams and Supplier Quality Assurance.
  • Ensures the site remains aligned with global standards and regulatory requirements by actively participating in system enhancements and upgrades.
  • Supports inspection readiness and audit management, contributing to a culture of continuous improvement and compliance.
  • Analyzes trends, identifies process gaps, and recommends targeted actions, helping the site exceed expectations for quality and compliance.
  • Performing system periodic reviews and ensuring the system usage,  training completion & application are inline with quality standards and data integrity requirements.

Here Is What You Need (Minimum Requirements)

  • Graduate/ Post Graduate with (or equivalent) with 4+ years of experience
  • Robust comprehension of cGMP, Data Integrity, and ALCOA principles
  • Exceptional organizational and communication skills
  • Proficiency in word processing and document formatting
  • Extensive experience with Microsoft Office applications, including Word, Excel, PowerPoint, and Visio
  • Ability to manage multiple tasks and projects simultaneously
  • Strong attention to detail and accuracy

Bonus Points If You Have (Preferred Requirements)

  • Relevant pharmaceutical experience
  • Demonstrated expertise in technical writing
  • Strong project management skills
  • Experience with electronic document management systems
  • Knowledge of regulatory requirements and guidelines
  • Ability to work independently and as part of a team
  • Excellent problem-solving skills
  • Strong interpersonal skills
Work Location Assignment: On Premise

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

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