Senior Executive QA - QMS

Job Summary

Senior Executive – QA (QMS) will be responsible for ensuring compliance with established quality systems and regulatory requirements throughout the product lifecycle. This role involves review of batch manufacturing and packaging documentation, execution of batch release activities in SAP, and effective coordination with cross-functional teams to support timely market dispatch of finished pharmaceutical products. The position plays a critical role in maintaining GMP compliance, managing risk assessments, change controls, and deviations, and driving continuous improvement through root cause investigations.

Key Responsibilities

• Independently audit Batch Manufacturing Records (BMRs), Batch Packaging Records (BPRs), Analytical Reports, and other associated documents of finished pharmaceutical products.
• Execute batch disposition and product release for market dispatch, including relevant entries in SAP.
• Coordinate with Production, Quality Control, Supply Chain, and Export Distribution departments for timely product release in SAP.
• Review and manage assigned risk assessments and change alerts effectively.
• Ensure timely communication, execution, and closure of risk assessments.
• Compile and provide Right First Time (RFT) data on a monthly basis and communicate findings to concerned departments for corrective actions.
• Report change controls and deviations in a timely manner in accordance with approved SOPs.
• Conduct investigations and root cause analysis for non-compliances identified during batch record audits.
• Prepare, review, and update Product Packaging Information Records for the Pakistan market.

Required Knowledge and Skills:

• Master’s degree in Chemistry/Analytical Chemistry, Pharm-D, or a related field, with 2–3 years of relevant experience in Quality Assurance / QMS within a pharmaceutical manufacturing environment.
• Strong understanding of GMP, QMS, change control, deviations, and risk management.
• Knowledge of change management, deviation handling, CAPA, and risk assessment processes in line with ICH and GMP requirements.
• Familiarity with batch record review, batch release activities, and documentation control within a regulated pharmaceutical environment.
• Ability to manage multiple quality activities simultaneously while meeting timelines for batch release and reporting.
• High level of attention to detail with a structured and compliance-focused approach.
• Strong written and verbal communication skills for clear documentation, reporting, and inter-departmental communication.