Krunal Patel

• Contributed innovative ideas and solutions to enhance team performance and outcomes.
• Worked with cross-functional teams to achieve goals.
• Worked successfully with diverse group of coworkers to accomplish goals and address issues related to our products and services.
• Worked successfully with a diverse group of coworkers to accomplish goals and address issues related to our products and services.

• Assigned daily tasks, ensured shift handovers, and monitored team performance to maintain operational efficiency. Trained new joiners and enforced adherence to SOPs and GMP.
• Supported in-line process checks, handled deviations, and implemented CAPA. Participated in investigations for OOS/OOT, change controls, and risk assessments to ensure compliance.
• Performed dry granulation via roller compactor for moisture-sensitive products. Operated octagonal and double-cone blenders for uniform mixing of actives and excipients.
• Conducted in-process checks (LOD, sieve analysis, bulk density, blend uniformity) and documented results in BMR/logbooks to maintain quality standards.

• Detail-oriented and proactive Line Leader with experience in overseeing fill preparation, packing operations. Remove department and Printing department in a pharmaceutical environment. Seeking to leverage leadership skills and technical expertise to ensure efficient and compliant packaging processes at Aspire Pharmaceuticals.
• Lead and manage a team of machine operators and packers to ensure smooth and efficient operations in the packing department.
• Documented batch processes per FDA and GMP standards. Led packing department team to ensure smooth and efficient operations.
• Documented batch processes per FDA and GMP standards. Led the packing department team to ensure smooth and efficient operations.
• Scanned, labeled, and processed materials per SOPs. Staged carts and inspected raw materials as per SOP guidelines.

Developed solid, liquid, and semi-solid dosage forms from lab scale to pilot batches.
Conducted pre-formulation, drug-excipient compatibility, and solubility studies.
Scaled up manufacturing processes and established Critical Process Parameters (CPPs).
Utilized QbD and DOE principles to optimize formulations and process controls.
Managed technology transfer to commercial production facilities