Quality Assurance Manager

Job Title: Quality Assurance Manager

Location:

About Fusion Scientific Laboratories

USFDA and EMA accredited pharmaceutical laboratory

Position Overview

Quality Assurance Manager

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.