Job Summary
The Assistant Quality Control Manager is responsible for supporting the QC Manager in overseeing daily laboratory operations, ensuring strict compliance with Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP).
This role involves supervising laboratory personnel, reviewing analytical data for raw materials, in-process, and finished products, leading Out-of-Specification (OOS) investigations, and maintaining inspection readiness for global regulatory bodies
Key Responsibilities
Laboratory Operations:
Assist in managing daily Quality Control laboratory activities.
Supervise chemical, microbiological, and physical testing of raw materials, packaging materials, in-process samples, and finished products.
Ensure timely analysis and reporting of laboratory results.
Coordinate laboratory workflow to meet production and release timelines.
Quality Compliance:
Ensure compliance with GMP, GLP, SOPs, and regulatory requirements.
Support internal and external audits, including regulatory inspections.
Monitor adherence to quality systems and laboratory best practices.
Participate in investigations related to deviations, out-of-specification (OOS), and out-of-trend (OOT) results.
Develop and execute Corrective and Preventive Actions (CAPA) to address root causes and prevent recurrence of quality issues.
Write, review, and update Quality Control Standard Operating Procedures (SOPs) to reflect changing regulations and process improvements.
Documentation & Reporting:
Review analytical reports, laboratory records, certificates of analysis, and test documentation.
Ensure proper documentation, filing, and record retention in compliance with regulatory standards.
Assist in preparing quality metrics and management reports.
Equipment & Method Management:
Oversee calibration, qualification, and maintenance of laboratory instruments and equipment.
Support analytical method validation, verification, and transfer activities.
Ensure availability of laboratory reagents, standards, and consumables.
Team Leadership:
Supervise and mentor QC analysts and laboratory staff.
Assist in staff training and competency development programs.
Promote a culture of quality, safety, and continuous improvement.
Safety & Continuous Improvement:
Ensure compliance with laboratory safety procedures and environmental standards.
Identify process improvement opportunities within QC operations.
Support implementation of CAPA (Corrective and Preventive Actions).
Required Education & Experience
Requirements
Bachelor's or Master's degree in Chemistry, Pharmacy, Pharmaceutical Sciences, Biochemistry, or a closely related scientific discipline.
Minimum of 5 to 8 years of hands-on experience in a pharmaceutical QC laboratory.
At least 2+ years in a supervisory, team-lead, or senior analyst role.