Quality Assurance- Senior Executive

SVR Drugs And Intermediates; Yadlapuru; On-site; INR 1,500,000 - 2,100,000; Full time

Job summary

SVR Drugs And Intermediates in Karnataka is seeking a Quality Assurance Senior Executive with 10-12+ years of API/bulk drug manufacturing experience to lead quality systems and ensure regulatory compliance.

You will review and approve SOPs, BMRs, specifications, and validation documents; manage deviations, CAPA, audits, and supplier assessments; coordinate with Production, QC, and other functions to drive continuous quality improvement.

Qualifications

• 10+年在药物API/大规模药物制造领域的经验。
• 具备cGMP与药品质量体系及监管要求的经验。
• 具备审查SOP、BMR、规格、工艺文件等质量文档能力。
• 能够处理偏差、CAPA、变更控制、OOS/OOT调查与风险评估。
• 参与内部、供应商、客户及监管机构审计与检查。
• 具备验证及确认文件的审查经验。
• 与生产、QC、仓储及其他部门协同以确保质量合规。
• 进行GMP培训并推动持续质量改进。

Responsibilities

• 确保符合cGMP、药品质量体系和监管要求。
• 审查并批准SOP、BMR、规格、工艺和质量文件。
• 处理偏差、CAPA、变更控制、OOS/OOT调查及风险评估。
• 支持内部、供应商、客户及监管机构审核与检查。
• 审查验证与确认文件。
• 与生产、QC、仓储及其他部门协调以确保质量合规。
• 开展GMP培训并推动持续质量改进计划。

Skills

Quality Assurance

Regulatory compliance

GMP

CAPA

Audits

Education

B.Pharm

M.Pharm

B.Sc./M.Sc. Chemistry

Job description

Quality Assurance Senior Executive

We are looking for an experienced Quality Assurance professional with 10–12+ years of experience in pharmaceutical API / bulk drug manufacturing.

Key Responsibilities:

• Ensure compliance with cGMP, pharmaceutical quality systems, and regulatory requirements.
• Review and approve SOPs, BMRs, specifications, protocols, and quality documents.
• Handle Deviations, CAPA, Change Controls, OOS/OOT investigations, and Risk Assessments.
• Support internal audits, vendor audits, customer audits, and regulatory inspections.
• Review validation and qualification documents.
• Coordinate with Production, QC, Warehouse, and other departments to ensure quality compliance.
• Conduct GMP training and support continuous quality improvement initiatives.

Qualification:

B.Pharm, M.Pharm, B.Sc./M.Sc. Chemistry or equivalent.

Location:

Kadechur, Karnataka.