Executive / Senior Officer - Quality Assurance - USV - Vadodara

Job Title:

Job Summary:

The Executive Quality Assurance is responsible for ensuring compliance with cGMP standards through effective execution of Validation, Annual Product Quality Review (APQR), and Quality Management System (QMS) activities. The role involves coordination with cross-functional departments, documentation management, and continuous quality improvement.

Key Responsibilities:

1. Validation:

• Prepare, review, and execute validation protocols and reports (Process, Cleaning, Equipment, HVAC, Utilities, etc.).
• Ensure timely qualification and requalification activities.
• Review and evaluate validation data and ensure compliance with regulatory and internal quality standards.
• Coordinate with production, engineering, and QC for smooth execution of validation activities.
• Maintain validation master plan and validation documentation repository.

2. Annual Product Quality Review (APQR):

• Coordinate collection and review of data from production, QC, and other departments for APQR.
• Prepare and compile APQR reports as per regulatory guidelines and internal SOPs.
• Identify trends, deviations, and opportunities for process improvements based on APQR findings.
• Ensure timely completion and approval of APQRs.

3. Quality Management System (QMS):

• Participate in implementation and maintenance of QMS elements (Change Control, Deviations, CAPA, Risk Management, Document Control, etc.).
• Ensure timely closure of QMS records and proper documentation.
• Support internal and external audits, including regulatory inspections.
• Contribute to continual improvement initiatives and ensure regulatory compliance.

Key Competencies:

• Sound understanding of cGMP, ICH, 21CFR, WHO, and regulatory requirements.
• Strong analytical, documentation, and communication skills.
• Proficient in handling QMS software (e.g., TrackWise, Veeva, or similar tools).
• Ability to work independently and as part of a team.
• Attention to detail and quality-focused mindset.

Preferred Skills:

• Experience in pharmaceutical manufacturing environment (oral solid dosage).
• Exposure to regulatory audits (USFDA, MHRA, EU, etc.).
• Knowledge of data integrity practices and electronic documentation systems.