Assistance Quality Control Manager (Pharmaceutical)

Job title : Assistance Quality Control Manager (Pharmaceutical)

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.