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
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.
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.
