Assistant Manager - Quality Assurance

Drlogy; Ahmedabad District; On-site; INR 600,000 - 900,000; Full time

Job summary

Drlogy is seeking an Assistant Manager – Quality Assurance to oversee CSV IT quality assurance activities and ensure compliance with GMP standards. The role involves documentation review, system validation, and training.

The ideal candidate will hold a B.Pharm or M.Pharm and have 6–10 years of experience in quality assurance and regulated computerized systems. Strong coordination with various departments and a focus on data integrity are essential.

Qualifications

• 6–10 years of experience in quality assurance in a formulation environment.
• Experience with CSV IT and GMP documentation.
• Strong knowledge of data integrity and regulated computerized systems.

Responsibilities

• Support computerized system validation activities for GMP-critical IT systems.
• Review and approve CSV documents including URS, validation plan, and test scripts.
• Ensure compliance with GMP, GAMP, data integrity, and regulatory expectations.
• Coordinate with various departments for quality assurance processes.
• Handle deviations and change control related to computerized systems.
• Train users on data integrity and compliance requirements.

Skills

Quality assurance

Computerized system validation

GMP documentation

Data integrity

Regulated computerized systems

Education

B.Pharm / M.Pharm

Job description

Assistant Manager – Quality Assurance

The Assistant Manager – Quality Assurance will be responsible for CSV IT quality assurance activities, computerized system validation, documentation review, compliance monitoring, and quality system support at Cadila Pharmaceuticals. Qualification: B.Pharm / M.Pharm with 6–10 years of experience in quality assurance, formulation environment, CSV IT, GMP documentation, data integrity, and regulated computerized systems.

• Support computerized system validation activities for GMP‑critical IT systems.
• Review and approve CSV documents including URS, risk assessment, validation plan, test scripts, and reports.
• Ensure computerized systems comply with GMP, GAMP, data integrity, and regulatory expectations.
• Coordinate with QA, IT, production, QC, engineering, vendors, and system owners.
• Review access control, audit trail, backup, restore, change control, and user management practices.
• Support validation of laboratory, manufacturing, quality, and documentation‑related computerized systems.
• Participate in system risk assessment, qualification, periodic review, and compliance monitoring.
• Handle deviations, change controls, CAPA, and investigation support related to computerized systems.
• Review SOPs and controlled documents related to CSV, IT compliance, and data integrity.
• Support audit readiness for computerized systems and electronic records.
• Train users on data integrity, system usage discipline, and CSV compliance requirements.
• Monitor CSV lifecycle activities and ensure timely documentation closure.
• Review vendor documents and support system qualification activities.
• Ensure formulation manufacturing systems remain validated and compliant.
• Promote strong data integrity and digital compliance culture across departments.