Senior QA Analyst

Job Title: Senior QA Analyst – Formulation

Location: Cherlapally
Department: Quality Assurance – Formulation
Industry: Pharmaceutical Formulations / Manufacturing
Employment Type: Full-Time

Job Summary:

We are looking for a highly skilled and experienced Senior QA Analyst – Formulation to join our Quality Assurance team. The candidate will be responsible for ensuring the highest standards of product quality, regulatory compliance, and documentation accuracy throughout the formulation and manufacturing lifecycle. The role also includes review and coordination of DMF (Drug Master File) related activities and documentation for domestic and international regulatory submissions.

Key Responsibilities:

• Review and approval of Batch Manufacturing Records (BMRs) and Batch Packing Records (BPRs).
• Ensure compliance with GMP, GLP, GDP, and company SOPs during all manufacturing and formulation processes.
• Conduct line clearance, in-process checks, and verification of documentation at each stage of formulation.
• Review analytical data, stability studies, validation protocols, and summary reports.
• Oversee and coordinate deviations, change controls, CAPA, OOS, and OOT investigations related to formulation batches.
• Review and maintain DMF (Drug Master File), PDR, and technical documents in line with global regulatory requirements (USFDA, EU, WHO, MHRA, TGA, etc.).
• Prepare, review, and ensure timely submission of DMF updates, Annual Product Reviews (APR/PQR), and other regulatory compliance documents.
• Coordinate with Regulatory Affairs, QC, R&D, and Production teams for smooth documentation flow and audit readiness.
• Participate in internal, external, and regulatory audits, ensuring corrective actions and compliance.
• Ensure data integrity, documentation accuracy, and record traceability across all QA activities.
• Provide training and support to QA team members on documentation, DMF preparation, and GMP compliance.

Desired Candidate Profile:

• Qualification: B.Pharm / M.Pharm / M.Sc in Chemistry or related field.
• Experience: Minimum 5–8 years in Quality Assurance (Formulation) within a regulated pharmaceutical company.
• Expertise in:
• DMF preparation and review (USDMF, EDMF, CEP, etc.)
• Regulatory documentation and dossier preparation
• Handling deviations, CAPA, and change control systems
• Data integrity and compliance audits
• Good understanding of ICH, WHO, USFDA, and EU GMP guidelines.
• Excellent analytical, communication, and documentation skills.

Job Type: Full-time

Pay: ₹300,000.00 - ₹700,000.00 per year

Work Location: In person