Akansha Pal
Lexington,KY
Summary
Detail-oriented quality assurance expert skilled in analytical testing and regulatory compliance. Demonstrates proficiency in managing quality system documentation, conducting investigations, and facilitating continuous improvement initiatives. Dedicated to ensuring compliance with industry standards and enhancing overall product quality.
Overview
7
7
years of professional experience
Work History
Analytical Quality Chemist 1
Piramal Pharma Solutions
Lexington, KY
05.2026 - Current
- Conduct required testing and lab activities (including third party and stability activities as requested) under current Good Manufacturing practices (cGMP) in support of new projects and manufacturing and including data interpretation, documentation and reporting of results, calibrations and PMs under the direction of senior staff
- Conduct required testing and lab activities (including third party and stability activities as requested) under current Good Manufacturing practices (cGMP) in support of new projects and manufacturing and including data interpretation, documentation and reporting of results, calibrations and PMs under the direction of senior staff
- Initiate lab investigations and deviations as per internal SOPs under the direction of QC Manager or designate (e.g.) out-of-specification reports)
- Initiate lab investigations and deviations as per internal SOPs under the direction of QC Manager or designate (eg. out-of-specification reports)
- Work as an effective team member to meet departmental goals, sharing knowledge with team members
- Reported troubleshooting issues to on-shift senior staff for resolution. (e.g. procedural, instrument or method issues.)
- Introduction to reviewing analytical documentation for analysis performed by other chemists under the direction of senior staff
- Contributed to development and sharing of knowledge in analytical chemistry and technology through active participation in relevant training and workshops.
- Promote and ensure safe and clean lab operations
Quality Assurance Specialist I
Sovereign Pharmaceuticals
Fort Worth, Texas
02.2025 - 03.2026
- Lead cross-functional teams for process improvement and document review.
- Maintain quality system documentation, aligned with the requirements of 21 CFR part 04,11, 210,211,and 820 Compliance.
- Manage Document Control
- Conduct Internal Audit to ensure compliance
- Prepare Annual Product Review (APR)
- Manage Events like Investigations, Deviations, CAPA, OOS, OOT
- Work on Product Complaints and Inquiries
- Review Phase II Stability Investigation studies
Sr Quality Assurance Specialist (Contract)
Synergy Bioscience, Inc
Dallas, Tx
06.2024 - 01.2025
- Coordinate and establish quality system documentation, aligned with the requirements of 21 CFR part 11, 210,211,600 and 820 as well as ISO17025.
- Filing for 510k, FDA renewal, CLIA, EPA for clients.
- Develop and deliver training on QA procedures and other critical needs.
- Authorize and coordinate quality assurance compliance activities, including tracking of deviation, OOS investigations and CAPAs to completion
- Conducts Internal Audits to ensure conformance to established SOPs, documents, corrective actions.
- Lead cross-functional teams for process improvement and document review.
- Establish systems for continuous improvement based on feedback from clients and department.
Quality Assurance Specialist (Contract)
Piramal Pharma Solutions
Sellersville, PA
11.2023 - 05.2024
- Assure that all departmental work is performed in compliance with GMP and FDA/EMA requirements.
- Work efficiently in the various computer-based systems (ERP, LIMS, Document Management System, Learning Management System, Quality Management System)
- Generated certificate of acceptance (C of A) for bulk and finished drug products and coordinated the tracking of finished batch status.
- Ensured consistency across multiple review projects by adhering to established protocols and procedures.
- Developed knowledge base for common issues encountered during reviews, streamlining future problem-solving efforts.
- Performed calibrations and verifications of laboratory equipment to ensure accurate measurements. of balances, calipers, etc. Direct cross-training within the department. Write, manage, and maintain SOPs, testing specifications, and methods. Maintain raw material reserve samples.
- 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).
Quality Assurance Specialist (Contract)
Amgen
Thousand Oaks, CA
05.2023 - 11.2023
- Verified that suppliers were properly approved and qualified.
- Updated team leadership on project developments to ensure alignment with goals. on quality metrics, highlighting consistency problems and production deficiencies.
- Maintained product compliance with industry regulations by staying up to date on relevant standards and guidelines and implementing necessary changes.
- Implement process improvements to increase productivity in quality assurance operations.
- Completed deviation forms and recorded inspection findings, collaborating with quality team members and department managers to implement procedural remedies.
- Addressed reported issues promptly, enhancing customer satisfaction through effective solutions.
- Perform standard first article inspections and random sampling inspections to verify adherence to customer standards.
- Conduct thorough audits of manufacturing processes, resulting in increased efficiency and reduced defects.
- Optimized workflow efficiency by introducing automation tools into the QA process.
- Improve product quality by implementing rigorous testing procedures and identifying areas for improvement.
- Analyze quality and performance data to support operational decision-making.
- Review and validate quality requirements for manufacturing planning, supplier purchase orders, and engineering specifications to meet contract compliance regulations.
- Inspect raw materials and finished products to verify quality and dispose items that did not meet safety requirements.
- Review annual product quality reviews of marketed products.
Quality Analyst
ScieGen Pharmaceuticals
Hauppauge, NY
04.2022 - 04.2023
- Interpret analytical data, converting to technical documentation for use in training manuals and standard operating procedures.
- Maintained complete, accurate test records, reviewed data for accuracy and trends, and communicated concerns to supervisor to support quality assurance.
- Create testing protocols to be used across product lines.
- Review and validate quality requirements for manufacturing planning, supplier purchase orders, and engineering specifications to meet contract compliance regulations.
- Ensure updating and maintenance of Batch Manufacturing Records and Quality Control testing protocols for raw materials, packaging materials, in-process testing, APIs, stability testing.
- Conducted thorough examinations of all in-process materials to verify compliance with quality standards for packaging, labeling, raw materials, excipients, drug product containers, and closures.
- Implemented in-process quality control and quality assurance operations for tablet and capsule filling, sealing, and packaging to ensure compliance with standards.
- Executed testing of process improvement characterization samples to evaluate effectiveness of enhancements., Participating in internal audit
- Ensure company's process compliance with GxPs (cGMP, GDP) and learn data error detection and correction.
- Perform Quality testing & inspections for raw materials, packaging components and labels in compliance with regulation.
Quality/Regulatory Affairs Intern
Eurythmia Medical Network
Boston, MA
01.2022 - 04.2022
- Audit incoming data points, collating information into usable planning packages for project management personnel.
- Assist in assembling project documentation for project manager, confirming inclusion of data and preliminary information.
- Researched industry trends to inform strategic solutions and development.
- Coordinated client communication during projects to ensure timely updates and alignment.
- Collaborate with senior leaders to create job bids for new projects.
- Tracked and recorded orders and change requests to maintain accuracy and team alignment.
- Maintain open communication by presenting regular updates on project status to customers.
Student Patient Care Associate
Northeastern University
Boston, MA
10.2021 - 04.2022
- Assisted with Covid-19 testing while following clinical guidelines.
- Assisted patients with safe transfers between healthcare facilities. and ambulation.
- Monitored and conveyed important patient information to healthcare staff, supporting effective treatment planning and care delivery.
- Facilitate smooth transitions between shifts by communicating pertinent patient information during detail handoff reports.
- Ensure patient's privacy and security, we adhere to the HIPAA confidentiality rule.
- Entered participant data into clinical research databases and maintained organized patient records in Broad Institute's and LSTC databases while ensuring a clean and safe patient environment.
- Assisted Northeastern University with informed consent process for Covid-19 screening, ensuring compliance and understanding among participants.
Quality Control Specialist
IPCA Laboratories Limited
Mumbai, IN
06.2019 - 11.2020
- Conduct and evaluate solid and liquid dosage form lab size trials.
- Perform appearance, conductivity, pH, osmolality, and HPLC testing.
- Work in the Regulatory Affairs department to learn about pharmaceutical law and the ICH Quality, Safety, and Efficacy requirements. Learn how to prepare dossiers for registration of formulations in various Rest of the World (ROW) markets and how to submit them.
- Regulated the unit's temperature to maintain stability.
- Review documents like Batch Manufacturing Record (BMR), Batch Processing Records (BPR), Prescriber's Digital Reference (PDR), Specifications, Standard Test Procedures (STP) and process validation protocols.
Education
Master of Science - Regulatory Affairs of Drugs, Biologics & MD
Northeastern University
Boston, MA12-2022
Bachelor of Pharmacy - Pharmacy
Mumbai University
Mumbai, IN06-2019
Skills
- Analytical testing
- GxP compliance expertise
- Quality system regulations
- Regulatory compliance expertise
- Clinical trial documentation
- Laboratory project coordination
- ERP and LIMS systems
- Technical documentation editing
- Adobe Systems Software- Microsoft Office proficiency
Publication
Hossain, A., Pal, A., & Salem, S. (2024). Development of method and analysis protocol for fatty acids derivatives of castor oil by using gas chromatography-mass spectrometry. Biocatalysis and Agricultural Biotechnology, 103408. https://doi.org/10.1016/j.bcab.2024.103408
Timeline
Analytical Quality Chemist 1
Piramal Pharma Solutions
05.2026 - Current
Quality Assurance Specialist I
Sovereign Pharmaceuticals
02.2025 - 03.2026
Sr Quality Assurance Specialist (Contract)
Synergy Bioscience, Inc
06.2024 - 01.2025
Quality Assurance Specialist (Contract)
Piramal Pharma Solutions
11.2023 - 05.2024
Quality Assurance Specialist (Contract)
Amgen
05.2023 - 11.2023
Quality Analyst
ScieGen Pharmaceuticals
04.2022 - 04.2023
Quality/Regulatory Affairs Intern
Eurythmia Medical Network
01.2022 - 04.2022
Student Patient Care Associate
Northeastern University
10.2021 - 04.2022
Quality Control Specialist
IPCA Laboratories Limited
06.2019 - 11.2020
Master of Science - Regulatory Affairs of Drugs, Biologics & MD
Northeastern University
Bachelor of Pharmacy - Pharmacy
Mumbai University