Komal Patel

Perform analysis of a variety of drug substances and drug products with
emphasis upon purity, content uniformity, and dissolution in a GMP-compliant
manner.
Possess good mechanical aptitude and be physically capable to perform lab
and general maintenance work.
Excellent scientific writing skills with the ability to troubleshoot analytical issues and
author deviation reports suitable for review by regulatory agencies.
Equipment calibration, Regulatory compliance, Raw material specifications,
Laboratory analysis, Reporting and Documentation.
Quality Management, Visionary leadership. Adaptability, Decision making, Planning,
organizing, Communication, Team work, Continuous learning, Critical thinking &
Problem Solving, Always ready to participate in additional lab training or other
training to be provided by the organization.
Microsoft Word, Excel, Power Point

Supervise and coordinate activities of teams engaged in collecting samples for
Quality assurance testing
● Perform detailed analysis to maintain quality standards of raw materials
● Accountable for implementation of CAPA and to ensure compliance status
against Product Recall, Critical complaint and Rcgulatory inspcction
obscrvations.
● Ensure tracking and timely closing of all CAPA raised through quality
documents and post effectiveness checks of CAPA.
● Participated in preparation ot’ audit compliance response report and ensuring
implementation of commitments.
● Ensured that Business needs are met regarding Regulatory c(lMP compliance
(MHRA, EU, FDA) tor Investigational Pharmaceutical Product packaging and
distribution worldwide
● Reviewed and comment of Process Validation Report (PVR) and Process Validation
Protocol (PVP)Review quality assurance instructions, specifications and schedules to
conduct tests and work assignments.
● Leveraged capability to efficiently work with minimal supervision in a virtual
environment.
● Prepared monthly QMS and Validation Presentation, also involved in
preparation of trend for deviation, OOS, OOT and CAPA.Train team members
for handling Hazardous Reagents like Ortho Chloro Phenol, Perchloric Acid,
Hydro Bromic Acid, etc.
● Monitored In-process checks in different dosage form like Tablets and
capsule
● Conducted audits of Manufacturing and Packaging Records and QA process
related documents to assure that documentation is free of errors and
complies with CGMP's and SOP's.
● Attended continuing education and training programs which were relevant to
the post and Personal development plan also to train team member on
current good manufacturing practice
● and other relevant SOPs Responsible for documenting, tracking and closing all CAPA
raised
● Ensured timely batch Release in interdepartmental as well as Finished
Product after verification of BMR and analysis results.
Customer Service Responsibility:
● Scan items and ensure pricing is correct.
● Greet customers and ask if they want paper or plastic.
● Take Money in the form of cash, credit card, or cheque.
● Ask for one or two forms of ID tom confirm identity.
● Validate Checks.
● Issue receipts, refunds, and credits.
● Count money in cash drawers at the beginning of shifts to ensure that amounts
are correct and that there is adequate change.
● Answer customer’s questions and get a manager if the answer doesn’t solve
the issue.
● Cash checks and provide change.
Pharmacy Assistant Responsibilty:
● Perform Duties in priority according to the role assigned on SOP
● Refer to Pharmacist all the Clinical inquires for example those related to medication
purposes use, recommended including prescription OTC, restricted sale products
diseases, and conditions professional fees and other inquires as required by law or
company policy.
● Set realistic customer expectations as to wait times and effectively communicate the time
to the customer
● Managing Customer inquiries both in person and over the phone
● Adhere to all confidentiality and privacy requirements, Administration work, front shop
merchandising duties, prescription workflow, and documentation

Education: BACHELOR OF SCIENCE (Chemistry) [2003-2006]
MG Science College – India (Equivalent to Canadian Bachelor degree (three
years), as assessed by World Education Services)
MASTER OF SCIENCE (Organic Chemistry) [2006-2007]
MG Science College – India (Equivalent to Canadian Master degree (two
years), as assessed by World Education Services)
Languages Known: English, Hindi and Gujarati