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 ControlSkills Required
- B. Pharm, M. Pharm, or M.Sc.
- 2-3 years (Master's) or 4-5 years (Bachelor's) experience in pharma/biotech QA, QC, or manufacturing
- Experience with change management processes
- Knowledge of risk assessment principles and tools
- Validation of manufacturing equipment
- Drug product process validations experience
- Familiarity with regulatory requirements and compendial changes
- Knowledge of regulatory guidelines, Good Documentation Practices, and Good Manufacturing Practices
- Thorough understanding of 21CFR 211, Pfizer Quality Standards, site procedures and processes
- Experience supporting inspections (USFDA, MHRA, TGA, WHO)
- Knowledge of chemical and microbiology testing
- Strong interpersonal and effective communication skills across levels
- Compliance-driven mindset and ability to work in cross-functional teams
What the Team is Saying
Pfizer Compensation & Benefits Highlights
-
Healthcare Strength — Multiple U.S. medical plan options include telehealth, comprehensive mental‑health support, fertility/family‑building benefits, transgender‑inclusive coverage, and certain Pfizer medications at no cost. A Wellbeing Wallet and wellness resources broaden the health and wellbeing offering.
-
Retirement Support — A 401(k) with company matching is paired with an additional Pfizer Retirement Savings Contribution, alongside company‑paid life and disability insurance. One‑on‑one financial planning support is provided through Fidelity.
-
Leave & Time Off Breadth — Paid time off spans vacation, holidays, and personal days, with additional caregiver and medical leave. U.S. parental leave commonly includes 12 weeks paid with options for additional unpaid bonding time and a return‑to‑work transition.
Pfizer Insights
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.
Gallery
Pfizer Offices
Hybrid Workspace
Employees engage in a combination of remote and on-site work.
