Senior Executive - DQA

Enzene Biosciences Ltd.; Pune District; On-site; INR 2,500,000 - 4,200,000; Full time

Job summary

Enzene Biosciences Ltd. seeks a seasoned Quality Assurance expert to develop and implement quality strategies that align with regulatory requirements across biopharmaceutical development.

You will drive integration of quality principles through development stages, ensure global regulatory compliance, and support submissions and inspections. Lead QMS, audits, CAPA, and cross‑functional collaboration with R&D, Manufacturing, and Regulatory Affairs.

Qualifications

• Master's degree in a Pharmacy, Life Sciences, or related field.
• Minimum of 6-8 years in biotechnology industries with at least 3 years in QA.
• Strong understanding of CDSCO, ICH, FDA, EMA and global regulations.

Responsibilities

• Develop and implement quality strategies aligned with regulatory requirements.
• Integrate quality principles into biopharmaceutical development stages.
• Ensure adherence to domestic and global regulatory requirements throughout product development.
• Support regulatory submissions and inspections with QA guidance.
• Establish and maintain QMS for developmental activities.
• Oversee document management and guidance on quality issues.
• Support technology transfer to GMP sites at different development stages.
• Collaborate with R&D, Manufacturing, Regulatory Affairs to align quality objectives.
• Provide QA expertise to project teams and foster a quality culture.
• Conduct internal audits and CAPA to improve processes.
• Drive process improvements, efficiency gains, and cost-effectiveness.
• Monitor regulatory updates to adapt quality strategies.

Skills

Regulatory knowledge

Quality leadership

Communication

Problem solving

Cross-functional collaboration

Education

Master's degree in Pharmacy/Life Sciences

Job description

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."