Arpita Patel

• Conduct microbiological testing and interpret data to verify compliance with product specifications.
• Perform visual inspections and maintain meticulous documentation per GDP standards.
• Operate and calibrate analytical instruments (pH meters, balances, spectrophotometers).
• Support investigations into non-conformances (OOS, deviations), contribute to CAPA implementation.
• Use SAP Quality Module for data entry, material traceability, and documentation retrieval.
• Collaborate with engineering and QA teams to ensure compliance with FDA 21 CFR Part 820 and internal QMS.

• Inspected vials and syringes for particulate matter, cosmetic defects, and fill volume using both manual and automated systems.

• Trained team members and ensured correct equipment setup (Dabrico visual inspection systems).
• Executed line clearance and documented inspection outcomes according to SOP and cGMP.

• Partnered with QA to support batch release and data integrity reviews.

• Prepared sterile and non-sterile formulations in compliance with USP 797 and 795.
• Conducted quality control on incoming raw materials and finished goods using analytical methods.
• Maintained aseptic conditions and accurate batch records per internal SOPs and FDA guidelines.

• Assisted licensed pharmacists in preparing and dispensing medications accurately and efficiently.

• Processed and verified prescriptions and insurance claims, ensuring compliance and HIPAA regulations.
• Maintained proper inventory levels by restocking medications and checking for expired items.

• Provided excellent customer service by addressing patient questions and resolving issues with compassion and professionalism.

• Accurately entered prescription orders and updated patient records using pharmacy management software.
• Collaborated with healthcare providers to clarify prescriptions and ensure patient safety.

• Ensured compliance with GMP, ISO 9001, and FDA guidelines across manufacturing and quality operations.
• Reviewed Batch Manufacturing Records (BMRs), managed deviations, CAPA, and change controls to maintain documentation accuracy and product integrity.
• Supported regulatory audits and inspections by preparing audit documentation and addressing audit observations effectively.
• Monitored and enforced quality management systems (QMS) protocols including document control, internal audits. and SOP revisions.
• Conducted in-process quality checks and final product inspections for iodine derivatives, APIs, and intermediates.
• Participated in validation activities including process, cleaning, and equipment validation (IQ/OQ/PQ)
• Tracked and analyzed quality metrics and trends to improve processes and reduce non-conformities.
• Delivered GMP and quality training to production and QC staff to promote compliance and awareness.
• Collaborated with production, R&D, and QC departments to ensure smooth implementation of quality systems.

• Assisted in the production of pharmaceutical products in compliance with GDP and SOPs, including tablet and capsule manufacturing.
• Operated and monitored production equipment, recorded batch data, and maintained accurate documentation.
• Participated in cleaning, sanitization, and line clearance procedures to ensure contamination-free production areas.
• Supported deviation reporting, change control, and quality assurance processes under supervision.
• Collaborated with cross-functional teams, including Quality Assurance, Engineering, and Supply Chain.
• Gained hands-on experience with batch records, inventory control, and in-process checks.
• Followed strict safety protocols and contributed to a culture of continuous improvement.