Associate - Quality Systems

Pfizer; Visakha Valley Road; On-site; INR 400,000 - 700,000; Full time

Job summary

Pfizer in India is seeking a Documentation and Quality Specialist to support GMP document management, PDOCs, SDS and electronic records. You will manage document lifecycle, archival, retention and change control in a fast-paced pharmaceutical environment.

The role requires a B.Pharma/M.Pharma/MSc with 1-4 years of experience, willingness to work in shifts, and strong written and verbal communication. Knowledge of ERRS, logbook management, and familiarity with AI tools like Copilot or ChatGPT is

Qualifications

• Knowledge of GMP Document and Record Management, including document issuance, retrieval, archival, retention, and disposition.
• Knowledge of PDOCs, SDS, p-Log, Therefore, CICR, and electronic document management systems.
• Knowledge of official print management, audit trail review, metadata verification, document scanning, and record tracking.
• Understanding of Document Lifecycle Management, including document creation, review, approval, issuance, archival, retrieval, retention, and obsolescence.
• Familiarity with Enterprise Records Retention Schedule (ERRS) requirements and records compliance practices.
• Knowledge of logbook management, secure bin management, and document storage administration.
• Understanding of change control, impact assessment, and Quality Systems processes.
• Experience using AI-powered tools, such as Microsoft Copilot and ChatGPT, to enhance productivity, streamline workflows, and improve operational efficiency.

Responsibilities

• Manage GMP document lifecycle including creation, review, approval, issuance, and archival.
• Ensure retention, retrieval and secure storage of records and logs.
• Apply change control assessments within Quality Systems frameworks.
• Utilize AI tools to streamline documentation and workflows.
• Collaborate across functions to maintain quality and compliance in documentation.

Skills

GMP Document Management

Electronic document management systems

Change control

Quality Systems

PDOCs

AI tools (Copilot/ChatGPT)

Education

B.Pharma / M.Pharma / MSc

Tools

AI tools (Copilot)

ChatGPT

Job description

Use Your Power for Purpose Every day, our unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our flexible, innovative, and customer-oriented culture is rooted in science and risk-based compliance. Whether you are engaged in development, maintenance, compliance, or research analysis, your contributions have a direct impact on patient care. By being part of our team, you help uphold a quality culture that adapts and evolves to meet the needs of patients, ensuring that every product we deliver is of the highest standard. Your role is crucial in maintaining this commitment and driving forward our mission to improve patient outcomes.

What You Will Achieve

• Knowledge of GMP Document and Record Management, including document issuance, retrieval, archival, retention, and disposition.
• Knowledge of PDOCs, SDS, p-Log, Therefore, CICR, and electronic document management systems.
• Knowledge of official print management, audit trail review, metadata verification, document scanning, and record tracking.
• Understanding of Document Lifecycle Management, including document creation, review, approval, issuance, archival, retrieval, retention, and obsolescence.
• Familiarity with Enterprise Records Retention Schedule (ERRS) requirements and records compliance practices.
• Knowledge of logbook management, secure bin management, and document storage administration.
• Understanding of change control, impact assessment, and Quality Systems processes.
• Experience using AI-powered tools, such as Microsoft Copilot and ChatGPT, to enhance productivity, streamline workflows, and improve operational efficiency.

Here Is What You Need (Minimum Requirements)

• B.Pharma, M.Pharma or MSC with 1 to 4 years of relevant experience in the pharmaceutical industry.
• Willingness to work in shifts-based operations as required by business needs.
• Strong written and verbal communication skills with the ability to collaborate effectively across functions.
• Document management & digital applications experience

Bonus Points If You Have (Preferred Requirements)

• Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance

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

To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers.

Quality Assurance and Control Pfizer careers are like no other. In our culture of individual ownership, we believe in our ability to improve future healthcare, and potential to transform millions of lives. We’re looking for new talent to join our global community, to unearth new innovative therapies that make the world a healthier place.