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
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Fundamental knowledge of manufacturing and quality control processes (solution preparation, filling, sterilization, visual inspection, packaging)
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Document review and Good Documentation Practices
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Basic knowledge of change control and risk assessment
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Knowledge of chemical and microbiology testing
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Interpersonal Skills: Effective communication with all staff from different levels; builds constructive and effective relationships
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Acts Decisively: Makes decisions in a timely manner based on available information
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Grows Self: Identifies individual development needs and works towards achieving those objectives
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Critical thinking and compliance mindset
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Ability to work in cross-functional teams
Core Responsibilities:
Quality Operations
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Review QC documents (BQ, CQ), batch records, and related documents
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Support shop-floor QA activities including GMP compliance monitoring and process checks
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Perform in-process checks and support batch documentation review
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Review SOPs, specifications, STPs, and study protocols
Quality Compliance
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Support audit activities, inspection readiness, and regulatory commitments
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Ensure adherence to cGMP, GDP, and regulatory requirements
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Support quality systems such as Change Control, CAPA tracking, and document management
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Assist in data integrity and documentation control activities
Quality Investigations
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Support deviation investigations and CAPA implementation
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Assist in root cause analysis using investigation tools
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Track investigation closure within timelines
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Ensure proper documentation of investigation records
Here Is What You Need (Minimum Requirements)
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B. Pharm/M. Pharm/M.Sc.
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Master’s Degree: 2–3 years
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Bachelor’s Degree: 4–5 years
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Experience in Pharma / Biotech QA, QC, or Manufacturing
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Change Management process experience
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Risk assessments principles and tools
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Validation of manufacturing equipment’s
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Drug Product Process validations
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Regulatory requirements
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Compendial Changes
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Knowledge on Regulatory Guidelines, Good documentation practices and Good Manufacturing Practices.
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Thorough understanding of 21CFR 211, Pfizer Quality Standards, site procedures and Processes
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Strong Interpersonal skills
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Ability to communicate effectively with all levels within the organization.
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Compliance driven approach, knowledge on cGMP and regulations.
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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
