NAPS apprentice

Quality Assurance (QA) Responsibilities

• Implement and monitor Good Manufacturing Practices (GMP) across production and warehouse areas.
• Review and approve Standard Operating Procedures (SOPs), Batch Manufacturing Records (BMR), and Batch Packaging Records (BPR).
• Conduct line clearance, in-process checks, and ensure compliance during manufacturing and packaging.
• Handle Deviation, Change Control, Out-of-Specification (OOS) and Out-of-Trend (OOT) investigations.
• Perform internal audits, coordinate regulatory inspections, and ensure CAPA closure.
• Ensure proper qualification and validation of equipment, utilities, and processes.
• Review quality metrics and support continual improvement initiatives.

Quality Control (QC) Responsibilities

• Conduct testing of raw materials, intermediates, finished products, and stability samples.
• Operate laboratory instruments such as HPLC, GC, UV, IR, Dissolution Apparatus, etc.
• Prepare and maintain test records, COAs, and ensure compliance with ALCOA principles (Data Integrity).
• Calibrate laboratory equipment and maintain calibration records.
• Investigate laboratory incidents, OOS/OOT, and support root cause analysis.
• Ensure safe handling and proper storage of chemicals, reagents, and reference standards.

Regulatory & Compliance

• Ensure compliance with WHO, USFDA, MHRA, EU GMP, and other regulatory guidelines.
• Support documentation and preparation for regulatory submissions and audits.
• Ensure adherence to data integrity, documentation practices, and company quality policies.

Skills & Competencies Required

• Strong understanding of GMP, GLP, and GDP.
• Knowledge of analytical techniques and lab instruments (for QC roles).
• Excellent documentation and reporting skills.
• Strong analytical, problem-solving, and decision-making abilities.
• Attention to detail and high level of accuracy.
• Ability to work in cross-functional teams.

Education & Experience

• B.Pharm / M.Pharm / B.Sc / M.Sc (Chemistry or related discipline).