Associate Manager - Quality Assurance / Compliance / Investigations

3d3 days ago

Pfizer

Visakhapatnam, IN · Full-time · INR 1,200,000 – INR 1,800,000

About this role

Responsible for independent management, review, and approval of Quality Assurance activities. Ensures implementation of quality systems, drives regulatory compliance, and leads investigations to maintain cGMP standards and inspection readiness.

Day-to-day responsibilities include reviewing and approving QC documents, batch records, validation protocols, SOPs, and study protocols. You will also participate in the Site Change Review Committee, assess critical changes, and provide quality oversight for manufacturing and laboratory operations.

Collaborates with cross-functional teams to resolve quality issues and provides technical guidance and mentoring to junior team members. Drives a quality culture and continuous compliance improvements while interfacing with regulatory agencies during inspections.

Opportunity to lead deviation investigations, ensure robust root cause analysis, and drive timely closure of CAPAs. Identifies process improvement opportunities and presents critical quality decisions to leadership, fostering professional growth in a global pharmaceutical environment.

Requirements

B. Pharm, M. Pharm, or M.Sc. degree
6–8 years of experience in Pharma/Biotech Quality Assurance, Quality Control, Compliance, or Investigations (Bachelor's) or 4–5 years (Master's)
Experience in a sterile dosage manufacturing facility
Expertise in change control and risk assessment principles and tools
Knowledge of investigation tools and root cause analysis methodologies
Experience in handling regulatory inspections (USFDA, MHRA, etc.)
Strong knowledge of manufacturing processes, quality control, and validation activities

Responsibilities

Review and approve QC documents, batch records, validation protocols, and reports
Review and approve SOPs, specifications, STPs, and study protocols
Ensure manufacturing quality compliance and adherence to procedures
Participate in Site Change Review Committee and assess critical changes
Lead, review, and approve deviation investigations and CAPA
Ensure robust root cause analysis and effective corrective/preventive actions
Provide quality oversight for manufacturing and laboratory operations
Lead audit and inspection readiness activities for internal, regulatory, and corporate inspections