We are seeking a dedicated professional to oversee and enhance our Quality Management System within a high-stakes pharmaceutical manufacturing environment. This role is pivotal in ensuring strict adherence to cGMP standards across injectable production lines. The successful candidate will lead documentation reviews, manage operational compliance, and drive continuous improvement through robust risk management and validation strategies. By maintaining the highest levels of quality assurance from raw material dispensing to final packaging, you will play a critical role in delivering safe and effective medical products to the global market.
Roles and Responsibilities
Implement and maintain a comprehensive Quality Management System (QMS) aligned with cGMP guidelines for injectable production.
Review and approve essential manufacturing documentation including Batch Manufacturing Records (BMR) and Batch Packaging Records (BPR).
Manage quality processes through digital platforms such as Caliber QAMS, DMS, and serialization tracking systems.
Lead Quality Risk Management (QRM) initiatives and oversee the investigation and closure of deviations, incidents, and OOS results.
Coordinate process and equipment validation protocols, ensuring all activities meet rigorous regulatory standards.
Supervise production team job allocations and provide critical training on media fills and aseptic protocols.
Support regulatory filings by preparing data for dossiers, DMFs, and product license applications for local and international authorities.
Desired Candidate Profile
Extensive experience in quality control or quality assurance within the pharmaceutical industry, specifically focusing on sterile or injectable manufacturing.
In-depth knowledge of cGMP compliance, aseptic processing, and Small Volume Parenteral (SVP) operations.
Proficiency in utilizing quality management software and track-and-trace serialization tools.
Strong background in drafting and auditing SOPs, validation protocols, and master batch records.
Demonstrated ability to implement effective CAPA plans following self-audits or regulatory inspections.
Expertise in monitoring cleanroom behavior and maintaining standards in classified production areas including Lyophilization and filling.
Role
Quality Control Professional (Injectables and SVP)