POONAM SAINI

· Designed and optimized comprehensive quality systems, procedures, work instructions, and processes to ensure seamless operations and regulatory compliance.

· Managed the processing and closure of electronic quality records, such as Customer Complaints, Issue Records, Nonconformance Records, CAPA/SCAR Records, and Change Controls.

· Conducted thermal chamber programming and lane studies to assess and enhance product quality and performance.

· Assisted in internal audits to ensure adherence to regulations, identifying areas for improvement, and implementing corrective actions.

· Created and reviewed SOPs, protocols, and documents to ensure accuracy, compliance, and effective communication of quality standards.

· Utilized Navision software for operational tasks, demonstrating proficiency in system management for streamlined processes.

· Facilitated vendors' license approvals and played a key role in the setup of new items in the system.

· Evaluated QMS records for potential trends, providing valuable insights for continuous improvement and risk mitigation.

· Supported Monthly Metrics through data analysis, contributing to informed decision-making for process enhancements.

· Conducted training sessions and contributed to the development of annual cGMP and Pharmacovigilance training presentations/courses.

· Managed complex projects, demonstrating the ability to handle diverse responsibilities effectively.

· Acted as a mentor to team members, providing guidance on quality management principles and best practices.

· Undertook other tasks as needed, showcasing adaptability and a commitment to tackling various challenges.

• Reviewing and developing validation reports for various temperature-controlled packaging units used for pharmaceutical cold chain products
• Shadowing validation personnel for validation of temperature-controlled packaging units (IQ,
• OQ, PQ)
• Assisted calibration of temperature loggers and sensors while maintaining records for the same
• Co-ordinated validation studies between different operational department to be completed on timely manner
• Programmed temperature sensors for validation studies using Cryopak software (Escort
• Console plus and console pro)
• Carried various lane studies using different temperature pack outs (Aerosafe, credocube) following the protocols and writing the reports for the same along with data analysis of the data recorded in the temperature loggers
• Monitoring and analyzing temperature data for storage facilities and logging and investigating events of alarms of OOS storage conditions
• Drafted, evaluated, and reviewed Annual Product Quality Reports, identifying adverse trends and ensuring compliance with regulatory standards
• Tracked stability lots and entered stability data into the Stability program, ensuring the assessment of product quality over time
• Reviewed batch records, product specifications, Certificates of Compliance, and Certificates of
• Analysis for product release in the Canadian market
• Assisted in the investigation, review, and disposition of product returns, destructions, and recalls
• Supported the change control process for Quality System Records to maintain GMP compliance
• Experience in reviewing product labels and promotional materials
• Conducted thorough research and analysis of regulatory requirements to ensure compliance throughout the drug development and marketing process
• Collaborated with internal and external stakeholders to provide regulatory guidance and support for drug submissions and compliance matters
• Assisted in the preparation of regulatory submissions and responses to Health Canada queries or requests for additional information
• Stayed updated on industry trends, regulations, and guidelines, and communicated relevant information to internal teams as necessary.

• Lead and complete the assigned projects by defining scope and impact, measuring/collecting process data, analyzing findings and potential future processes and planning/implementing process improvements and controls
• Throughout the project cycle, perform tasks including:
• Providing progress updates
• Escalating project related issues to Senior Managers and Executive Sponsors as appropriate
• Managing the contributions of project team members
• Proactively identify and solve problems with process improvement teams, managing the change process
• Provide Lean coaching, training, and mentorship to clinical staff and leadership
• Analyze, interpret, and report key metrics for operations and administrative teams
• Developed CAPA’s and executed them
• Completed G.M.P
• Documents, such as the Batch Record, cleaning & sanitizing logs, housekeeping logs, and other documents/log records pertaining to manufacturing.

• Single point of contact for patients enrolled in the support program and prescribing physician, if applicable
• Informs the patient about all program offerings – for example case management support, reimbursement support, self-injection training, prescription coordination and ongoing compliance
• Report all adverse Events (AE) and Product Technical complaints (PTC) immediately or as soon as possible upon becoming aware of the event as per current policies and procedure
• Data entry, dispensing and compounding according to a specific procedure
• Patient problem solving and third-party issues
• Maintaining the drug inventory and regularly placing and putting away the pharmacy and
• Over the Counter products order on shelve
• Assist in the development of policies and protocols for chronic disease management, geriatric care, and mental health to develop systems and communication protocols to facilitate patient follow up.

• Strong knowledge of protein powder manufacturing processes, including blending, drying, and packaging
• Observed activity within the packaging, manufacturing, and warehouse areas to ensure compliance with GMP
• Proficient in quality control procedures, ensuring compliance with industry standards and regulations
• Experienced in conducting product testing, analyzing results, and implementing corrective actions
• Made quality decisions regarding Manufacturing, Packaging, and Warehouse issues as required according to SOP's
• Escalated significant issues to Quality Management
• Skilled in maintaining production equipment, troubleshooting issues, and performing routine maintenance
• Familiarity with Good Manufacturing Practices (GMP) and Hazard Analysis and Critical
• Control Points (HACCP) guidelines
• Excellent attention to detail and ability to follow Standard Operating Procedures (SOPs)
• Collected samples of raw materials, bulks, and finished products for laboratory testing
• Managed retention samples of finished products, bulks, and raw materials, ensuring proper organization and maintenance of the retention room
• Assisted in maintaining the stability program to monitor product quality over time
• Contributed to companywide GMP training initiatives
• Prepared Production, Plant Sop and Format and trained the machine operators accordingly
• Prepared manufacturing records and updated online documentation to meet production and cGMP requirements
• Followed safe work processes and ensured safety appliances are utilized during production activities in shifts to create a safe working environment