Manager – DQA

• Oversee and support the overall activities during the product development life cycle from Quality perspective in R&D (API and intermediates)
•  Author / Review the SOPs/work directions required for implementing the Quality Systems in R&D activities as per GLP and regulatory requirements. Ensure effective implementation of SOPs/ work directions.
• Review and approve technology transfer, product specification, analytical method validation, method transfer, qualification, calibration, process validation protocol and reports. Ensure effective execution of these activities.
• Periodic audits of R&D laboratory. Ensure online documentation and review lab notebooks, PDR/LFR documents, analytical documents and stability data. Effective maintenance of R&D records, distribution and archival systems
• Perform cGMP audit of R&D facilities and operations. Assist the team in auditing contract manufacturers / vendors / contract testing laboratory.
• Coordinating in responding to all customer queries / audit findings related to R&D department. Institutionalize a system and track timely closure of CAPAs and audit findings
• Ensure R&D team practices, systems and documentation are in compliance with respect to data integrity norms.
• Implement systems for Change Control and Lab investigations in R&D.
• To handle customer and regulatory audits.
• Provide quality related inputs to new projects, existing project, up gradations etc.
• Participate in identification of Key Starting Material (KSM) / Registered Starting Material (RSM) and ensure that it is correctly identified.
• Participate in handling of Out of Specification, Out of Trends, Deviation, Batch failure, Rejections, investigations and CAPA implementation at site.
• Establish raw material standards by studying manufacturing / R&D requirements -conferring with suppliers.
• Coordination and support Regulatory Affairs team during dossier submissions.
• Review in line with the current expectations of QbD in product development.
• Review the Product development reports and evaluation of the CPPs and CQAs.
• Evaluate the feasibility of the new product requirements and supports in planning the design of experiments

Pharma QA, R&D experience

MSc