Senior Executive - DQA

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.