Senior Quality Assurance Executive

osition: Senior QA Executive

Department: Quality Assurance (QA)

Reports To: QA Manager / Head Quality Assurance

Location: Badlapur, Thane

Employment Type

Full-Time/Permanent

Key Responsibilities

Quality Management System (QMS)

• Review, prepare, and approve SOPs, specifications, protocols, reports, and quality documents.• Manage deviations, incidents, OOS, OOT, change controls, CAPA, and risk assessments.• Ensure timely closure of quality events and maintain compliance with internal timelines.• Monitor effectiveness of CAPA implementation.

Documentation Control

• Review Batch Manufacturing Records (BMR), Batch Packing Records (BPR), and associated documentation.• Ensure Good Documentation Practices (GDP) compliance.• Maintain controlled documents and archival records.

Validation & Qualification

• Review qualification and validation protocols and reports.• Support Process Validation, Cleaning Validation, Equipment Qualification, and Computer System Validation (where applicable).• Ensure validation documents comply with regulatory expectations.

Audit & Compliance

• Participate in internal audits and self-inspections.• Support customer, regulatory, and certification audits.• Prepare compliance reports and ensure timely implementation of audit observations.

Regulatory Compliance

• Ensure compliance with cGMP, WHO-GMP, Schedule M, ICH Guidelines, and applicable regulatory requirements.• Support regulatory inspections by preparing documentation and responding to observations.

Training

• Conduct GMP, GDP, SOP, Data Integrity, and Quality System training.• Maintain training records and evaluate training effectiveness.

Investigation & Risk Management

• Lead investigations related to deviations, customer complaints, and quality incidents.• Perform Root Cause Analysis (RCA) using quality tools.• Implement effective CAPA and monitor effectiveness.

Cross Functional Coordination

• Coordinate with Production, QC, Warehouse, Engineering, and Regulatory Affairs.• Support new product introduction and technology transfer activities.• Ensure smooth implementation of quality initiatives.

Continuous Improvement

• Identify opportunities for process improvement.• Participate in quality improvement projects.• Support digitalization and quality excellence initiatives.

Required Qualifications

• Bachelors or master’s degree in pharmacy (B.Pharm/M.Pharm), and Chemistry discipline.

Experience

• 2-6 years of experience in Quality Assurance within Pharmaceutical, API and Formulation, • Experience in regulated manufacturing environments will be preferred.

Required Skills

Technical Skills

• cGMP & GDP• Documentation Review• Deviation Management• CAPA• Change Control• OOS/OOT Investigation• Risk Assessment• Validation Documentation• Internal Audit• Regulatory Compliance• Data Integrity (ALCOA++)• Root Cause Analysis• Microsoft Excel, Word, and PowerPoint

Behavioral Skills

• Strong analytical ability• Leadership and mentoring skills• Effective communication• Attention to detail• Problem-solving ability• Time management• Team collaboration• Decision-making skills

Preferred Knowledge

• WHO-GMP• Schedule M• ICH Guidelines• Data Integrity (ALCOA++)• Quality Risk Management (ICH)• Pharmaceutical Documentation Practices