Associate (Quality Assurance – Operations/ Compliance/ Investigations)

Pfizer

Remote

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.

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Quality Assurance and Control