Executive / Senior Executive Drug Substance Quality Assurance (DSQA)

Why This Role Matters

The Executive / Senior Executive – Drug Substance Quality Assurance (DSQA) plays a critical role in ensuring that drug substance manufacturing operations consistently meet current Good Manufacturing Practice (cGMP) standards and global regulatory expectations. In a highly regulated pharmaceutical environment, maintaining quality at the shop floor level is essential to safeguarding product integrity, patient safety, and regulatory compliance.
This role directly impacts the reliability of manufacturing processes by overseeing line clearance, reviewing batch documentation, monitoring in-process activities, and ensuring adherence to validated procedures. By actively participating in Quality Management System (QMS) processes such as deviations, change controls, and CAPA, the position supports continuous improvement and strengthens compliance culture.
Working within a fast-evolving pharmaceutical organisation focused on innovation, this role contributes to building robust quality systems that support regulatory inspections, international market approvals, and sustainable growth in drug substance manufacturing.

Job Description

The Executive / Senior Executive – DSQA will be responsible for ensuring cGMP compliance at the shop floor for Drug Substance (DS) manufacturing operations. The position involves active oversight of manufacturing activities, review of documentation, validation support, and participation in quality systems processes.
The candidate will work closely with production, quality control, engineering, and regulatory teams to ensure seamless compliance with established procedures and regulatory guidelines. The role requires strong technical knowledge of DS manufacturing processes, validation activities, and quality documentation systems.
This position is based in Pune and is open to candidates with 2–9 years of relevant experience in pharmaceutical Quality Assurance, particularly in Drug Substance or Active Pharmaceutical Ingredient (API) environments.

Key Features of the Role:

• Position: Executive / Senior Executive – DSQA
• Department: Quality Assurance
• Location: Pune
• Experience Required: 2–9 Years
• Qualification: M.Sc / M.Pharm
• Exposure to global regulatory standards (USFDA, EMA, WHO preferred)
• Direct involvement in shop floor QA and QMS activities
• Opportunity to work in an innovation-driven pharmaceutical organisation

Responsibilities

• Perform manufacturing line clearance activities for Drug Substance operations
• Ensure proper execution and compliance of in-process checks during manufacturing
• Conduct routine GMP rounds at the DS facility and document observations
• Review online Batch Manufacturing Records (BMR) for accuracy, completeness, and compliance
• Review and approve process validation and cleaning validation protocols and reports
• Review and manage Standard Operating Procedures (SOPs) and related documentation
• Coordinate sample collection and submission as per BMR, specifications, and validation protocols
• Perform shop floor compliance rounds and track corrective actions
• Prepare and support Annual Product Quality Review (APQR/PQR) documentation
• Initiate and manage Change Controls, Deviations, Incidents, and CAPA
• Participate in investigations, root cause analysis, and QMS improvement initiatives
• Ensure regulatory readiness for audits and inspections
• Conduct risk assessments for critical manufacturing and quality processes
• Maintain continuous oversight to ensure adherence to cGMP standards

Required Qualifications

The ideal candidate will be a detail-oriented and proactive Quality Assurance professional with strong exposure to Drug Substance manufacturing environments.

Educational Requirements:

• M.Sc in relevant Life Sciences discipline OR
• M.Pharm
• Strong academic foundation in pharmaceutical sciences and quality systems

Experience and Skills:

• 2–9 years of experience in pharmaceutical Quality Assurance
• Hands-on experience in DS or API shop floor QA activities
• Strong understanding of cGMP and regulatory compliance requirements
• Experience in BMR review and documentation control
• Knowledge of process validation and cleaning validation
• Familiarity with in-process control systems
• Experience handling deviations, change controls, and CAPA
• Strong analytical, investigation, and problem-solving abilities
• Effective communication and cross-functional coordination skills
• Ability to work in a dynamic, fast-paced manufacturing environment

Salary Insights

Compensation will be competitive and aligned with industry standards based on experience and qualifications. The organisation offers growth-oriented career opportunities, exposure to global regulatory environments, and a performance-driven work culture.

Company Overview

Enzene is an innovation-driven pharmaceutical organisation committed to disrupting the pharmaceutical industry through cutting-edge solutions and advanced manufacturing capabilities. The company emphasises quality excellence, scientific innovation, and regulatory compliance while fostering a culture powered by pioneers and forward-thinking professionals.
At Enzene, employees are regarded as the organisation’s greatest asset. The company promotes collaboration, accountability, and continuous improvement to support global regulatory standards and deliver high-quality pharmaceutical products to international markets.

FAQs

Q1. Is Drug Substance experience mandatory?
Yes, hands-on exposure to DS or API shop floor QA activities is highly preferred.

Q2. What regulatory exposure is expected?
Experience with USFDA, EMA, WHO, or other global regulatory guidelines is preferred.

Q3. Is this role focused on documentation only?
No. The role includes active shop floor oversight along with documentation review and QMS activities.

Q4. What level of experience is suitable?
Candidates with 2 to 9 years of relevant QA experience are eligible.

Q5. Is validation experience required?
Yes, understanding and review of process validation and cleaning validation documentation is expected.

Application Tips

• Highlight direct experience in DS/API shop floor QA activities
• Mention regulatory audit exposure (USFDA, EMA, WHO)
• Provide examples of handling deviations, CAPA, and change control
• Showcase validation documentation review experience
• Emphasise involvement in risk assessment and QMS investigations
• Demonstrate cross-functional collaboration with production and QC teams