Use Your Power for Purpose
Responsible for independent management, review, and approval of Quality Assurance activities. Ensures implementation of quality systems, drives regulatory compliance, leads investigations, and collaborates with cross-functional teams to maintain cGMP standards and inspection readiness.
What You Will Achieve
Role Responsibilities:
- Strong knowledge of manufacturing processes, quality control, and validation activities (process, cleaning, analytical methods, equipment, utilities)
- Advanced technical document review and approval capability
- Expertise in change control and risk assessment
- Strong knowledge of chemical and microbiological testing
- Knowledge of investigations tools and root cause analysis methodologies
- Understanding of manufacturing operations, engineering, and validation systems
- Experience in handling regulatory inspections
- Accountability: Self-driven, proactive, and responsible for quality outcomes
- Critical thinking and strong compliance mindset
- Strong time management and problem-solving abilities
- Interpersonal Skills: Builds strong cross-functional relationships and communicates effectively across all organizational levels
- Decision Making: Makes timely, independent, and risk-based quality decisions
- Leadership Skills: Provides guidance, coaching, and technical direction to team members
Core Responsibilities:
Quality Operations
- Review and approve QC documents (BQ, CQ), batch records, validation protocols, and reports
- Review and approve SOPs, specifications, STPs, and study protocols
- Review stability reports, APRs, and trend reports
- Ensure manufacturing quality compliance and adherence to procedures
- Participate in Site Change Review Committee (SCRC) and assess critical changes
- Provide quality oversight for manufacturing and laboratory operations
Quality Compliance
- Ensure implementation and effectiveness of Quality Management Systems (Change Control, CAPA, Deviations)
- Lead audit and inspection readiness activities (internal, regulatory, corporate)
- Interface with regulatory agencies and support inspections (USFDA, MHRA, etc.)
- Ensure compliance with cGMP, GDP, and global regulatory requirements
- Drive quality culture and continuous compliance improvements
- Review and approve quality system documentation and risk assessments
Quality Investigations
- Lead, review, and approve deviation investigations and CAPA
- Ensure robust root cause analysis and effective corrective/preventive actions
- Drive timely closure of investigations and escalation of critical issues
- Utilize advanced investigation tools and methodologies
- Ensure investigation quality meets regulatory expectations
Leadership & General Responsibilities
- Provide technical guidance and mentoring to junior team members
- Coordinate with cross-functional teams for resolution of quality issues
- Present critical quality decisions to leadership
- Identify process improvement opportunities and drive efficiency initiatives
- Ensure timely closure of action items and commitments
- Report and escalate critical non-compliance issues
Here Is What You Need (Minimum Requirements)
- B. Pharm/M. Pharm/M.Sc.
- Master’s Degree: 4 – 5 years
- Bachelor’s Degree: 6 – 8 years of experience in Pharma / Biotech Quality Assurance / Quality Control / Compliance / Investigations of sterile dosage manufacturing facility
- Change Management process
- Risk assessments principles and tools
- Validation of lab equipment’s
- Drug Product Process validations
- Regulatory requirements
- Compendial Changes
- Knowledge on Regulatory Guidelines, Good documentation practices and good manufacturing practices.
- Adhering to Site Procedures and corporate polices
Preferred Requirements
- 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