Job Title: Associate Manager – Manufacturing Compliance
Company: Pfizer
Location: India – Vizag (On Premise)
Employment Type: Full-Time
Job ID: 4953022
Experience Required: Minimum 7 years in pharmaceutical manufacturing compliance, quality assurance, or audit readiness roles.
About Pfizer
Pfizer Global Supply (PGS) is committed to delivering high-quality pharmaceutical products worldwide. With a patient-centric approach, PGS ensures that every product meets strict quality standards and regulatory compliance. Joining Pfizer means contributing directly to patient safety while driving excellence in manufacturing operations and compliance.
Role Summary
The Associate Manager – Manufacturing Compliance will lead and manage manufacturing compliance activities, focusing on inspection readiness, audit responses, and quality risk assessments. The role will coordinate cross-functional teams to maintain compliant, audit-ready operations and support continuous improvement initiatives within manufacturing.
Key Responsibilities
Inspection Readiness & Audit Management
Prepare and manage responses to internal and external audit observations.
Propose corrective and preventive actions (CAPAs) and gain alignment with SMEs and Quality Assurance.
Conduct readiness assessments, mock audits, walkthroughs, and gap analyses across manufacturing areas.
Coordinate inspection logistics and cross-functional preparation for regulatory inspections.
Track and monitor CAPAs, commitments, and improvement actions to ensure timely closure.
Quality Risk & Compliance Management
Prepare Quality Risk Assessments (QRM) for equipment, processes, and operations.
Initiate and manage Change Control Forms (CCFs) including pre-approval, implementation, and closure.
Conduct gap assessments of PQS, CAS, RONA, and other systems, and implement mitigation plans.
Identify opportunities for process improvements to enhance compliance and inspection readiness.
Collaboration & Continuous Improvement
Drive a culture of continuous inspection readiness across all manufacturing departments.
Ensure all documentation and records in manufacturing are audit-ready and compliant with cGMP.
Support teams in understanding regulatory expectations and maintaining adherence to standards.
Actively contribute to projects, independently or in collaboration with cross-functional teams, to improve compliance processes.
Qualifications & Experience
Master’s degree in Science or relevant field.
Minimum 7+ years of experience in pharmaceutical manufacturing, quality assurance, or compliance.
Strong knowledge of Good Manufacturing Practices (cGMP) and regulatory expectations.
Proven ability to collaborate effectively with cross-functional teams and ensure detailed, accurate execution of compliance activities.
Excellent communication, organizational, and project management skills.
Preferred Qualifications
Technical knowledge of software such as QTS, EQMS, PDOCS, SDS, and SAP systems.
Previous experience in pharmaceutical manufacturing operations.
Why Join Pfizer?
This role provides the opportunity to directly impact patient safety by ensuring compliant and high-quality manufacturing practices. You will play a critical role in inspection readiness, quality compliance, and continuous process improvement, contributing to Pfizer’s mission of delivering safe and effective medicines globally.
Work Location: On Premise – Vizag, India
Pfizer is an equal opportunity employer and complies with all applicable employment legislation.
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