Associate (Quality Assurance – Operations/ Compliance/ Investigations)

Use Your Power for Purpose

Responsible for execution and review support of Quality Assurance (Operations/ Compliance/ Investigations) activities including document review, shop-floor QA support, deviation handling, and quality systems support to ensure compliance with cGMP and regulatory requirements .

What You Will Achieve

Roles Responsibilities

Fundamental knowledge of manufacturing and quality control processes (solution preparation, filling, sterilization, visual inspection, packaging)

Document review and Good Documentation Practices

Basic knowledge of change control and risk assessment

Knowledge of chemical and microbiology testing

Interpersonal Skills: Effective communication with all staff from different levels; builds constructive and effective relationships

Acts Decisively: Makes decisions in a timely manner based on available information

Grows Self: Identifies individual development needs and works towards achieving those objectives

Critical thinking and compliance mindset

Ability to work in cross-functional teams

Core Responsibilities:

Quality Operations

Review QC documents (BQ, CQ), batch records, and related documents

Support shop-floor QA activities including GMP compliance monitoring and process checks

Perform in-process checks and support batch documentation review

Review SOPs, specifications, STPs, and study protocols

Quality Compliance

Support audit activities, inspection readiness, and regulatory commitments

Ensure adherence to cGMP, GDP, and regulatory requirements

Support quality systems such as Change Control, CAPA tracking, and document management

Assist in data integrity and documentation control activities

Quality Investigations

Support deviation investigations and CAPA implementation

Assist in root cause analysis using investigation tools

Track investigation closure within timelines

Ensure proper documentation of investigation records

Here Is What You Need (Minimum Requirements)

B. Pharm/M. Pharm/M.Sc.

Master’s Degree: 2–3 years

Bachelor’s Degree: 4–5 years

Experience in Pharma / Biotech QA, QC, or Manufacturing

Change Management process experience

Risk assessments principles and tools

Validation of manufacturing equipment’s

Drug Product Process validations

Regulatory requirements

Compendial Changes

Knowledge on Regulatory Guidelines, Good documentation practices and Good Manufacturing Practices.

Thorough understanding of 21CFR 211, Pfizer Quality Standards, site procedures and Processes

Strong Interpersonal skills

Ability to communicate effectively with all levels within the organization.

Compliance driven approach, knowledge on cGMP and regulations.

Should face national and international inspections such as USFDA, MHRA, TGA & WHO

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