As a Product Owner, I oversee the end-to-end process of Product Lifecycle Management (PLM), managing all stages from design and development through to validation, continued process verification (CPV), and post-launch monitoring. I lead and coordinate cross-functional teams to ensure the successful execution of product strategies, regulatory compliance, and continuous product improvement.Key Responsibilities & Achievements:PLM Stage 1 to 3 Oversight: Managed the entire PLM lifecycle, from process design (Stage 1), through process validation (Stage 2), to the transition to CPV (Stage 3), ensuring alignment with both regulatory requirements and company objectives.Technical Risk Assessment (TRA): Conducted in-depth TRA to identify, assess, and mitigate risks early in product development, ensuring robust product quality and regulatory compliance.Process Validation (PV) & Control: Led PV activities to validate manufacturing processes, ensuring product consistency and conformance to predetermined specifications and standards.CPV & Statistical Analysis: Oversaw CPV activities post-validation, including conducting statistical and trend analysis to monitor process stability, detect variations, and drive continuous improvement.Change Control Management: Managed the change control process, assessing the impact of changes during all stages of product development and ensuring proper documentation and implementation.Feasibility & Stability Trials: Supervised the manufacturing of feasibility trial batches and stability batches, ensuring successful scale-up from pilot to commercial production while maintaining product quality and process consistency.CMO (Contract Manufacturing Organization) Induction & Collaboration: Coordinated with CMOs for smooth product transition, ensuring technical transfer, training, and alignment on quality standards and manufacturing processes.

As a Product Owner overseeing the Product Lifecycle Management (PLM) process, I managed key stages of product development, from early-stage design to post-market monitoring. Key Responsibilities:-PLM Stage 1 (Process Design): Led the design and execution of the PLM Stage 1 process, including Technical Risk Assessment (TRA) and Process Control Strategy (PCS) development to ensure robust and scalable manufacturing processes.-Stage 2 (Process Validation): Managed the process validation activities, ensuring that manufacturing processes met predefined performance criteria and were compliant with industry standards.-Stage 3 (CPV Transition): Oversaw the transition from process validation to Continued Process Verification (CPV), ensuring that products consistently met quality and regulatory requirements.-Tech Transfer Management: Directed all technical activities related to tech transfer, ensuring seamless knowledge and process transfer between development, manufacturing, and commercial teams.-Cross-Functional Collaboration: Coordinated with R&D, manufacturing, quality control, and regulatory teams to ensure alignment and successful execution of product development and validation strategies.-Regulatory Compliance: Ensured that all technical documentation, including validation reports, TRA, and PCS, complied with regulatory standards (e.g., FDA, EMA) and industry best practices.-PPR Report Generation: Involved in the generation of Product Performance Review (PPR) reports, ensuring that product performance, stability, and quality trends were continuously monitored and reported.-Risk Mitigation: Identified and mitigated potential risks during product development, ensuring timely corrective actions were implemented to maintain product integrity and compliance.-Process Optimization: Contributed to continuous process improvement initiatives, identifying opportunities to enhance efficiency, reduce costs, and improve product quality throughout the product lifecycle.

-Data collection and analysis to assess product performance and process stability-Continued Process Verification (CPV) to ensure consistent product quality-Trend analysis to monitor key performance indicators (KPIs) and identify opportunities for improvement-Supporting product robustness assessments and recommending corrective actions-Collaboration with cross-functional teams to drive product and process optimization

-Leading manufacturing operations for granulation, compression, coating, and blistering processes-Ensuring consistent quality and efficiency in tablet production (core, coated, chewable)-Conducting in-process checks, troubleshooting, and optimizing production workflows-Managing and training production staff to maintain high performance-Implementing and adhering to GMP and industry regulations to ensure product integrity-Continuous process improvement and waste reduction