Associate- Quality Systems

Posted Yesterday
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Vizag, Vishākhapatnam, Andhra Pradesh, IND
Hybrid
Mid level
Artificial Intelligence • Healthtech • Machine Learning • Natural Language Processing • Biotech • Pharmaceutical
We’re in relentless pursuit of breakthroughs that change patients’ lives.
The Role
In this role, you will manage document control, ensure compliance with quality standards, and execute tasks for Quality Systems functions.
Summary Generated by Built In
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. Whether you are involved in development, maintenance, compliance, or research analysis, your contribution directly impacts patients.
What You Will Achieve
In this role, you will:
  • Prepare and review essential documentation, including GMP, GLP, and GCP manuals.
  • Responsible and Managing of Document Management Life Cycle and Record Management
  • Issuance, Retrieval, Archival and Control of GMP Documents/Records and DSMs (GMP documents) through Manual and Electronic systems.
  • Secure bin management
  • Knowledge on PDOCs, p-log and SDS Applications
  • Ensure compliance with Enterprise Records Retention Schedule (ERRS) maintained by the enterprise records and Information Management (eRIM) group.
  • Location mapping & tracking of documents/ records archived in Active Record Centers.
  • Competency in MS office, Adobe Acrobat and documentation data base systems
  • Execute tasks supporting Quality Systems functions and oversee Documentation Control and administrative functions of the DMS repository.

Here Is What You Need (Minimum Requirements):
  • Bachelor's Degree (Chemistry/Pharmacy) with 4+ Years of Experience or Master's Degree (Chemistry/Pharmacy) with 3+ Years of Experience
  • Proficiency in Document Management and Control
  • Experience with Computer Software Validation Concepts
  • Familiarity with regulatory requirements and compliance standards
  • Effective communication skills

Bonus Points If You Have (Preferred Requirements):
  • Project Planning experience
  • Lean or Six Sigma experience
  • Knowledge of Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP)
  • Strong problem-solving skills
  • Excellent time management and organizational skills
  • Adaptability in a dynamic work environment
  • Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity. Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use

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.
Quality Assurance and Control

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The Company
HQ: New York, NY
121,990 Employees
Year Founded: 1848

What We Do

Our purpose ensures that patients remain at the center of all we do. We live our purpose by sourcing the best science in the world; partnering with others in the healthcare system to improve access to our medicines; using digital technologies to enhance our drug discovery and development, as well as patient outcomes; and leading the conversation to advocate for pro-innovation/pro-patient policies.

Why Work With Us

We are the inventors, the problem solvers, the big thinkers — those who surmount any hurdle to deliver breakthrough medicines to the people who are counting on them the most.

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Employees engage in a combination of remote and on-site work.

Typical time on-site: Not Specified
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