Akansha Pal

• Sample pharmaceutical raw materials. Sample and inspect packaging components and printed literature.
• Work efficiently in the various computer-based systems (ERP, LIMS, Document Management System, Learning Management System, Quality Management System)
• Calibrations and verifications of balances, calipers, etc.Direct cross-training within department. Write, manage, and maintain SOPs, testing specifications, and methods. Maintain raw material reserve samples.
• Assure that all departmental work is performed in compliance with GMP and FDA/EMA requirements
• Maintained strong attention to detail while reviewing numerous documents daily, ensuring consistent quality and accuracy.
• Maintained strict confidentiality with sensitive client information, adhering to industry standards and company policies.
• Conducted in-depth research to strengthen the overall quality and credibility of each review.
• Ensured consistency across multiple review projects by maintaining strict adherence to established protocols and procedures.
• Contributed to the development of a knowledge base for common issues encountered during reviews, streamlining future problem-solving efforts.
• Stayed up-to-date on industry trends and best practices, incorporating relevant information into reviews as needed.

• Ensure that suppliers are properly approved and qualified
• Provided regular updates to team leadership on quality metrics by communicating consistency problems or production deficiencies.
• Ensured product compliance with industry regulations by staying up-to-date on relevant standards and guidelines, implementing necessary changes to maintain conformance.
• Implemented process improvements to increase productivity in quality assurance operations.
• Completed deviation forms and recorded findings of inspection process, collaborating with quality team members and department managers to implement procedural remedies.
• Updated inspection journals and daily summary logs with quality-related data.
• Enhanced customer satisfaction by addressing reported issues promptly and providing effective solutions.
• Performed standard first article inspections and random sampling inspections to verify adherence to customer standards.
• Conducted thorough audits of manufacturing processes, resulting in increased efficiency and reduced defects.
• Optimized workflow efficiency by introducing automation tools into the QA process where appropriate.
• Improved product quality by implementing rigorous testing procedures and identifying areas for improvement.
• Analyzed quality and performance data to support operational decision-making.
• Completed supporting documentation for testing procedures, data capture forms, equipment logbooks and inventory forms.
• Performed routine maintenance and calibration on testing equipment.
• Reviewed and validated quality requirements for manufacturing planning, supplier purchase orders, and engineering specifications to meet contract compliance regulations.
• Inspected raw materials and finished products to verify quality and disposed items that did not meet safety requirements.
• Review annual product quality reviews of marketed products

• Interpreted analytical data, converting to technical documentation for use in training manuals and standard operating procedures.
• Maintained complete, accurate and legible test records, reviewing data for accuracy and trends and communicating concerns to supervisor.
• Input data into spreadsheets or electronic databases to build complete documentation of testing and troubleshooting procedures.
• Performed routine maintenance and calibration on testing equipment.
• Recorded and organized test data for report generation and analysis.
• Created testing protocols to be used across product lines.
• Reviewed and validated quality requirements for manufacturing planning, supplier purchase orders, and engineering specifications to meet contract compliance regulations.
• Ensured updating and maintenance of Batch Manufacturing Records and Quality Control testing protocols for raw materials, packaging materials, in-process testing, APIs, stability testing.
• Examination of all in-process materials, packaging materials, labeling, raw materials, excipients, drug product containers, closures, and in-process materials
• Implemented in-process quality control & quality assurance (IPQC & IPQA) operations for tablet and capsules filling, sealing, and packaging line.
• Testing of process improvement characterization samples, Participating in internal audit
• Ensured company's process compliance with GxPs (cGMP, GDP) and learned data error detection and correction.
• Performed Quality testing & inspections for raw materials, packaging components and labels in compliance with regulation.

· Acquired knowledge of industry trends and developed solutions and strategy through effective research.

• Assisted in assembling project documentation for project manager, confirming inclusion of data and preliminary information.
• Audited incoming data points, collating information into useable planning packages for project management personnel.
• Managed client communication distribution during ongoing projects.
• Collaborated with senior leaders to create job bids for new projects.
• Tracked and recorded open and closed orders and change requests to prevent errors, keeping all team members aligned with current demands.
• Maintained open communication by presenting regular updates on project status to customers.

• Assisting Northeastern University in obtaining informed consent from testing individuals for the Covid-19 screening
• Ensure patient's privacy and security, we adhere to the HIPPA confidentiality rule.
• Under the monitoring of site management, helping in the aid of Covid-19 testing in compliance with clinical guidelines.
• Filling up and maintaining participant written information in the Broad Institute's clinical research database and the LSTC database. Maintained clean, safe, and well-organized patient environment.
• Assisted with patient transfers and ambulation.
• Monitored, tracked, and conveyed important patient information to healthcare staff to help optimize treatment planning and care delivery.
• Facilitated smooth transitions between shifts by communicating pertinent patient information during detailed handoff reports.

• Conducted and evaluated solid and liquid dosage form lab size trials.
• Performed appearance, conductivity, pH, osmolality, and HPLC testing.
• Worked in the Regulatory Affairs department to learn about pharmaceutical law and the ICH Quality, Safety, and Efficacy requirements. Learned how to prepare dossiers for registration of formulations in various Rest of the World (ROW) markets and how to submit them.
• Learned and examined how to regulate the unit's temperature is maintained.
• Reviewed documents like Batch Manufacturing Record (BMR), Batch Processing Records (BPR), Prescriber's Digital Reference (PDR), Specifications, Standard Test Procedures (STP) and process validation protocols.