Senior Executive - DQA

Enzene Biosciences Ltd; Maharashtra; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Enzene Biosciences Ltd. in India seeks an experienced DQA professional to develop and implement quality strategies across biopharmaceutical development.

You will ensure compliance with CDSCO, ICH, FDA and EMA, support regulatory submissions, and lead QA activities from development through transfer. The role requires 6–8 years in biotech with 3 years in QA, strong communication, and problem-solving skills to influence cross-functional teams.

Qualifications

• Master's degree in Pharmacy or Life Sciences or related field.
• 6–8 years in biotechnology industries with at least 3 years in a QA role focused on developmental stages.
• Strong regulatory knowledge including CDSCO, ICH, FDA, EMA for biopharmaceutical development.
• Experience with QMS, CAPA, internal audits, and supporting regulatory submissions.

Responsibilities

• Develop and implement quality strategies aligned with organizational goals and regulatory requirements.
• Drive integration of quality principles into biopharmaceutical development.
• Ensure adherence to local and global regulatory requirements throughout product development.
• Provide QA guidance to project teams and support regulatory inspections and submissions.
• Establish and maintain quality management systems for developmental activities.
• Oversee document management and CAPA to address non-conformances.
• Support technology transfer activities to GMP sites at different stages of development.
• Collaborate with R&D, Manufacturing, Regulatory Affairs and other departments to align quality objectives.
• Provide expertise to ensure quality throughout the organization.

Skills

Quality strategy

Regulatory knowledge (CDSCO, ICH, FDA,

Communication

Problem solving

Education

Master's degree in Pharmacy or Life Sciences

Job description

"Role & Responsibilities - DQA"

• Develop and implement quality strategies aligned with organizational goals and regulatory requirements.
• Drive the integration of quality principles into all stages of biopharmaceutical development.
• Ensure adherence to domestic as well as global regulatory requirements (e.g., local FDA, USFDA and EMA,) throughout product development.
• Support regulatory submissions and inspections, providing guidance on quality matters.
• Establish and maintain effective quality management systems (QMS) for developmental activities.
• Oversee document management control and provide guidance related to quality issues.
• Support technology transfer activities to transfer process as well as methods to GMP sites at different stages of product development
• Partner with Research & Development, Manufacturing, Regulatory Affairs, and other departments to ensure alignment on quality objectives.
• Provide QA expertise and guidance to project teams, fostering a culture of quality throughout the organization.
• Conduct internal audits and assessments to monitor compliance with quality standards and procedures.
• Drive corrective and preventive actions (CAPA) to address non-conformances and improve processes.
• Champion initiatives for process improvements, efficiency gains, and cost-effectiveness within QA and across functional areas.
• Monitor industry trends and regulatory updates to proactively adapt quality strategies.
• Strong understanding of CDSCO, ICH, FDA, EMA, and other global regulatory requirements applicable to biopharmaceutical development.
• Good understanding of Biopharmaceutical Product development activities like Procees characterization studies, Product charaxterization and Biosimilarity studies, Method development and validation etc.
• Excellent communication and problem-solving skills. Ability to influence and collaborate effectively across diverse teams.

Qualification

Master's degree in a Pharmacy, Life Sciences, or a related field (e.g., Biology, Biotechnology, Biochemistry, Pharmacy).

Experience

Minimum of 6-8 years in biotechnology industries, with at least 3 years in a QA role focused on product developmental stages.