Kunjal Patel

Dynamic Quality Assurance and Injectable drug manufacturer with 14 years experience having both skills of QA and Production, working with regulatory agencies such as FDA, ANVISA, and MHRA and overseeing materials inspection, scheduling production, and conducting weekly physical inventories. Focused decision-maker with showed the ability to lead cross-functional teams in the design, development, and launch of leading-edge solutions and processes.

  Quality Assurance Specialist                                                                                    July 2022 - Feb 2023

 Rogue Processing, Niverville, MB, Canada                                           

• Developed and reviewed all SOPs related to a new cannabis plant, and regularly reviewed them biannually while creating supporting documents to ensure the production of quality cannabis products.
• Managed all processing activities such as sanitation verification, environmental monitoring, raw material review and release, deviation investigation and CAPA, batch record review, and product label and CoA review while helping to develop and maintain site preventive control plans.
• Acted as a site contact person, ensuring company document and inventory control programs are followed and assisting with SOP development and process improvement to ensure quality cannabis products.
• Conducted a thorough review of batch records and associated documents to ensure quality and safety before releasing finished products for sale.
• Ensured completeness and accuracy of various production documentation while adhering to Good Documentation Practice.
• Implemented standards, methods, and procedures for inspecting, testing, and evaluating the precision, accuracy, and reliability of company products while ensuring compliance with in-house and/or external specifications and standards such as GMP, GGP, GPP, GDP, and ACMPR.
• Reviewed and assessed quality-related customer complaint investigations while supporting continuous quality improvement through participation in HACCP.
• Qualified new production rooms with equipment and materials for use while collaborating with Quality Control, Regulatory Affairs, Manufacturing, and Product Development departments to ensure compliance with Health Canada regulations and guidelines.

Machine Operator and Assembler                                                                                  Jan 2022 - July 2022

IVC Vita Health Products, Winnipeg, MB, Canada                                               

• Involved Performed Quality checks such as Weight Variation, Thickness, Diameter, Dissolution Test, Hardness Test, and Friability Test during machine operation to ensure adherence to high-quality standards and product specifications.
•  Operated various machines, including FETTE 3200I, COUTREY, and UNIPRESS, and maintained accurate GDP documentation for everyday processes such as setting up, assembling, running, disassembling, and cleaning of machinery and workspace. 
• Completed all documentation related to compression area operations and processing of encapsulation or compression products in a timely and accurate manner, following GDP guidelines.

Senior Executive                                                                                                                  Mar 2017 - Oct 2021 

Intas Pharmaceuticals, Ltd., Ahmedabad, India                                                                     

• Led the manufacturing of injectable drug products by planning, scheduling, directing work, and overseeing batch release activities through the Execution of Online Electronic Batch Records on the shop floor while achieving production KPI targets through effective supervision of over 50 employees.
• Prepared and reviewed SOPs, IQ, 0Q, PQ Protocols of different equipment such as Autoclave, Vial and ampoule Washing Machine, Depyrogenation Tunnel, Filling Machine, Sealing Machine, and Lyophilizer. Performed cleanroom qualification and POA tests and monitored aseptic and clean area core to ensure continual compliance.
• Maintained compliance with GDP and cGMP by effectively training employees on related topics, performing quality checks following relevant SOPs, and managing and supervising Aseptic Filling operations of 4 Aseptic Filling lines.
• Led internal department quality audits and external quality audits such as USFDA, MHRA, and ANVISA. Initiated deviations through software and implemented CAPAs by using effective problem-solving skills.
• Successfully manage Successfully managing and supervising complex aseptic filling operations involving multiple lines, automated filling machines, RABs technology, and autoclaves. Expertise in planning and executing 24-hour operations, from job order generation in SAP to drug manufacturing, filtration, and filling.
• Maintained the quality of all product documentation (paper and electronic) as per GDP and cGMP, reviewed vendor documents, and followed up related to qualification documents. Additionally, completed Batch Record Reviews and daily shift reports for output, efficiency, and downtime.
• Possessed strong knowledge of production and related cGMPs and GDP practices, including governmental regulations – 21CFR 210, 211. Participated in cost reduction programs and increased revenue by 28.55% annually through improvements in operations, quality, safety, and administration. 
• Completed batch record reviews and daily shift reports for output, efficiency, and downtime, maintained a visible presence on the production floor for maintaining it per audit daily, and helped resolve issues related to production/output.   

Senior executive                                                                                                                Apr 2016 - Mar 2017

Astral Steritech Pvt. Ltd., Baroda, India                                                                                

• Successfully managed and led a team of 2 production staff in a full-fledged sterile dry powder parenteral filling plant, developing and executing production schedules based on business demands.
• Conducted rigorous FAT, SAT, IQ, OQ, and PQ procedures to verify the functionality and performance of new types of equipment, ensuring their suitability for use in a production environment.
• Coordinated with supporting departments to carry out routine activities and ensured daily areas were presentable for audit purposes.
• Strictly adhered to GMP, system and procedure compliance, and the latest requirements to ensure zero market complaints.
• Experienced in handling MHRA and USFDA audits of injection facilities at a senior level and as HOD.
• Maintained and evaluated environment monitoring records to ensure product quality and safety.

Senior executive                                                                                                                Sep 2012 – Apr 2016

Cadila Healthcare Ltd. (Zydus Group), Ahmedabad, India                                              

• Extensive experience in successful installation of new production lines, area qualification and equipment qualification, including conducting FAT for new equipment, such as LSI Lyophilizer, Machine Fabric Steam Sterilizer, and N.K. Pharma Capping Machine.
• Proficient in weekly planning of production schedules, issuing raw materials and PPM for batch manufacturing and filling process, and adhering to SOPs and cGMPs to manufacture pharmaceutical products.
• Skilled in equipment preparation and performing CIP and SIP of equipment, as well as training and guiding trainee chemists, operators, and workers for proper gowning and works handle into classified areas.
• Strong documentation skills, including preparing batch manufacturing records, IQ, OQ, and PQ protocols, and SOPs related to production areas, as well as handling process validation, area validation, and instrument calibration.
• Experienced in facing and preparing for audits by regulatory agencies such as WHO GMP, USFDA, and MCC, and familiar with IQ, OQ, and PQ of different equipment, such as Autoclave, Vial Washing Machine, Vial Depyrogenation Tunnel, Vial Filling Machine, Vial Sealing Machine, and Lyophilizer.

Production Officer                                                                                                             Aug 2009 - Sep 2012

Sun Pharmaceuticals Ltd, Halol, India                                                                               

• Proficient in operating and validating various equipment used in pharmaceutical production such as Vial filling machine, Vial washing machine, Vial sealing machine, autoclave, and Lyophilizer.
• Skilled in preparing and reviewing Standard Operating Procedures (SOPs) related to production activities.
• Ability to coordinate and follow up with planning and warehouse teams to ensure timely dispensing of materials, availability of materials, and receipt of finished goods.
• Experienced in coordinating with QA/QC teams for in-process/intermediate/bulk sampling, system-related work, and equipment validation and calibration.3
• Well-versed in facing and preparing for audits by regulatory bodies such as WHO GMP, USFDA, TGA, MHRA, and ANVISA, and conducting periodic media fill activities. Also, capable of assisting in initial and subsequent validation of equipment and processes.

Jr. Production Executive                                                                                                Dec 2007- Aug 2009

Lyka Labs Ltd., India                                                                                                 

• Strong experience in managing multiple areas of pharmaceutical production, including the washing, manufacturing, and aseptic filling areas, as well as manual operation of a Lyophilizer.
• Skilled in supervising daily production activities, allocating work among operators, and preparing shift schedules, while ensuring compliance with WHO GMP regulations and audit preparation.
• Proficient in batch manufacturing of parenteral products, verifying dispensed raw materials, and ensuring workers and operators receive adequate training on SOPs. Additionally, highly knowledgeable in operating various equipment, including ampoule and vial washing machines, depyrogenation tunnels, filling and sealing machines, and sterilizers.

UNIVERSITY OF MYSORE                                                                                                      Mar 2005 - MAR 2007 

Master's Degree in Microbiology.

Sardar patel UNIVERSITY                                                                                               Mar 2002 – June 2005

Bachelor's Degree in Microbiology