Quality Assurance Manager

Job Title: Quality Assurance Manager

Location: Rabale, Navi Mumbai

Experience: 10 15 years

Department: Quality Assurance

Employment Type: Full-time

Reports To: Quality Head

About Fusion Scientific Laboratories

Fusion Scientific Laboratories is a USFDA and EMA accredited pharmaceutical laboratory based in Rabale, Navi Mumbai, offering world-class services in Formulation Development, Analytical Solutions, and Integrated Pharmaceutical Services (CDMO). We partner with pharmaceutical companies globally to deliver compliant and innovative solutions across the drug development lifecycle.

Position Overview

We are looking for a highly experienced Quality Assurance Manager to lead quality oversight for oncology product development, formulation, and pilot manufacturing, with a strong focus on compliance in both production and Quality Control (QC) Laboratory environments. The ideal candidate will have in-depth knowledge of GMP, regulatory compliance, and oncology product handling, with proven experience supporting regulatory inspections and audit readiness.

Key Responsibilities

General Quality Assurance Responsibilities

• Ensure end-to-end GMP compliance across formulation development, pilot manufacturing, and quality control functions for oncology products.
• Review and approval of Batch Manufacturing Records (BMRs), analytical reports, and validation protocols for oncology drug substances and products.
• Lead deviation investigations, OOS/OOT management, and CAPA implementation in a timely and compliant manner.
• Maintain and improve quality systems such as Change Control, Risk Assessment, Quality Metrics, and Audit Trails.
• Ensure effective training programs are in place for staff involved in oncology manufacturing and testing, including PPE use and containment protocols.
• Support and host regulatory audits and client inspections; ensure constant audit readiness.
• Implement and monitor Data Integrity (ALCOA+) practices across all functions.

Quality Oversight of cGMP QC Laboratory

• Oversee and ensure compliance of the QC laboratory with current GMP and GLP requirements specific to oncology products.
• Verify compliance with analytical method SOPs, regulatory compendia (USP, EP, IP), and internal specifications.
• Support implementation of Good Documentation Practices (GDP) in laboratory notebooks, logbooks, and electronic systems.
• Monitor proper functioning, calibration, and preventive maintenance of all critical QC instruments (e.g., HPLC, GC, ICP-MS, LC-MS/MS, etc.).
• Ensure environmental monitoring (EM) and microbiological testing for sterile oncology products are performed and reviewed per SOP.
• Facilitate timely investigation and closure of laboratory incidents, deviations, and out-of-specification (OOS) results.
• Collaborate with the QC and Analytical Development teams to ensure smooth and compliant execution of:
• Method transfers
• Reference standard qualification
• Sample management and chain of custody
• Oversee the archiving and retention of QC documents and raw data in accordance with regulatory and company requirements.

Required Qualifications & Experience

• Master's degree in Pharmaceutical Sciences, Chemistry, or a related discipline.
• 10–15 years of progressive experience in Quality Assurance, with exposure to oncology formulations, pilot-scale manufacturing, and cGMP QC laboratories.
• In-depth knowledge of ICH guidelines, USFDA, EMA regulatory expectations, and WHO GMP.
• Prior experience supporting regulatory inspections and/or client audits in a CDMO or oncology manufacturing setup.
• Strong understanding of HPAPI containment protocols, analytical method validation, and data integrity controls.

Key Competencies

• Expertise in oncology product QA, QC laboratory compliance, and GMP system management
• Strong leadership and cross-functional collaboration skills
• Sound decision-making and risk assessment capabilities
• Proficiency in regulatory documentation and audit management
• Detail-oriented with a strong sense of ownership and accountability

Why Join Fusion Scientific Laboratories?

• Be part of a growing, USFDA and EMA-accredited pharmaceutical laboratory focused on oncology innovation.
• Collaborate with top-tier pharmaceutical clients across the globe in a CDMO environment.
• Access cutting-edge technologies, a strong quality culture, and opportunities for professional advancement.
• Competitive salary, supportive leadership, and a high-performance work environment.