Job Description – Sr. QA Chemist

Department: Quality Assurance
Designation: Senior QA Chemist / Sr. Executive – QA
Industry: Pharmaceutical Manufacturing
Experience: 5+ Years
Qualification: M.Sc. Chemistry / M.Pharm / B.Pharm / B.Sc. Chemistry or equivalent

Job Purpose

To ensure compliance with cGMP, company Quality Management Systems, regulatory requirements, and established SOPs by monitoring manufacturing and laboratory activities, reviewing quality documentation, and supporting investigations, audits, and continuous quality improvement.

Key Responsibilities

• Review and approve BMR/BPR, analytical data, specifications, SOPs, protocols, and quality records.
• Perform QA oversight of manufacturing, dispensing, packing, and laboratory activities.
• Conduct and document line clearance, in-process checks, area inspections, and compliance checks.
• Handle and review deviations, incidents, OOS/OOT, CAPA, and Change Controls.
• Participate in root-cause analysis and risk assessments and ensure effective CAPA implementation.
• Review QC analytical records and ensure compliance with approved specifications and procedures.
• Support batch record review and batch release activities.
• Prepare, review, and revise SOPs, formats, protocols, reports, and other GMP documents.
• Ensure adherence to GDP, GMP, GLP and Data Integrity/ALCOA+ principles.
• Support internal, customer, regulatory, and GMP audits/inspections and coordinate responses to audit observations.
• Participate in self-inspections and GMP compliance audits.
• Support cleaning validation, process validation, qualification, and validation-related activities where applicable.
• Monitor compliance with SOPs, GMP requirements, training requirements, and quality standards.
• Review and investigate customer complaints, product returns, and product quality issues.
• Maintain QA records and ensure timely closure of quality events.
• Coordinate with Production, QC, Engineering, Warehouse, R&D, and Regulatory Affairs for quality-related activities.
• Identify compliance gaps and recommend continuous improvement and quality-system enhancements.
• Ensure timely completion of assigned QA activities and maintain inspection readiness.

Required Technical Skills

• Strong knowledge of cGMP, GDP, GLP and pharmaceutical QA systems.
• Knowledge of ICH, WHO GMP, US FDA and EU GMP requirements is desirable.
• Hands-on experience in Deviation, CAPA, Change Control, OOS/OOT and investigations.
• Knowledge of Batch Manufacturing Records / Batch Packing Records.
• Good understanding of Data Integrity and ALCOA+.
• Knowledge of SOP preparation, review and document control.
• Experience in audit preparation and audit response.
• Understanding of risk assessment, validation and qualification activities.
• Good knowledge of analytical chemistry and pharmaceutical manufacturing processes.
• Working knowledge of MS Office, QMS/EDMS/LIMS/SAP or equivalent systems is an advantage.

Desired Competencies

• Strong analytical and problem-solving skills.
• Attention to detail and quality mindset.
• Good written and verbal communication.
• Ability to investigate quality issues independently.
• Good coordination with cross-functional teams.
• Ability to work under deadlines and maintain compliance.
• Strong documentation and report-writing skills.

Key Performance Indicators (KPIs)

• Timely review and release of batch documentation.
• Timely closure of deviations, CAPAs and Change Controls.
• Audit/inspection