Quality Control, Sterile Compounder, GMP, USP, ICH, FDA, EU regulation
Resume:
Wasee Intemas
Oshawa, Ontario
Contact: 289-***-**** ********@*****.***
Summary of Qualifications:
● BSc in Pharmaceutical Chemistry with 2 years of experience in the pharmaceutical industry.
● 4 years of WET lab experience with a solid working knowledge of sample preparation/testing following SOPs and performing analysis using analytical instrumentation as per USP (HPLC, UPLC, UV-Vis, IR, Karl Fischer Titration, pH meter, viscometer).
● 5 years of proficient computer literacy skills (55 wpm) with expertise in Microsoft Office applications (Excel, Word), data analysis, and management systems (e.g., LIMS, OpenLab CDS, SAP, Empower, Kroll, Nexxsys, ChemStation).
● In-depth understanding of regulatory guidelines including USP testing, ICH guidelines, Chemistry Manufacture Control (CMC), HACCP, FDA, EU regulations, and QMS, ensuring compliance with pharmaceutical quality control and assurance standards.
● Demonstrated expertise in GMP and QMS, with a comprehensive understanding of ALCOA+, SISPQ, CAPA, and SOPs.
● Excellent communication skills both verbal and written, for effective collaboration with team members and clients, with a strong aptitude for documentation and attention to detail.
● Highly motivated individual with the ability to multitask efficiently and thrive in a collaborative team environment.
Technical Skills:
● Solid working knowledge of GMP, QMS, and HACCP practices including ALCOA+, SISPQ, CAPA, and SOPs.
● Proven track record in product formulation and manufacturing processes, with hands-on experience in executing and optimizing manufacturing procedures to meet quality and efficiency objectives.
● Certified in High-Performance Liquid Chromatography (HPLC) for assay/potency testing, impurity testing, method validation/development, and technology transfer.
● Proficient in HPLC, UPLC, UV-Vis, IR, Karl Fischer Titration, pH meter, viscometer, TOC, and chemical and physical identifications testing as per USP guidelines, with a demonstrated ability to interpret results effectively.
● In-depth understanding of USP testing, ICH guidelines, Chemistry Manufacture Control (CMC), FDA, EU regulations, HACCP and QMS, ensuring compliance with regulatory standards and best practices in pharmaceutical quality control and assurance.
Education
University of Ontario Institute of Technology
Oshawa, Ontario
Bachelors of Science - Pharmaceutical Chemistry (Major) Biology (Minor)
● Instrumental Analytical, Nanochemistry, Pharmacology & Toxicology, Pharmaceutical Biotechnology, Microbiology
Academy of Applied Pharmaceutical Sciences (AAPS)
North York, Ontario
Post-Grad Diploma - Quality Assurance & Quality Control (QAQC)
● Product Formulation and Manufacturing, HPLC Certification (Assay, Method validation/development and Technology transfer), Dissolution Testing, Technical Writing and Scientific Communication, GMP/GLP/GDP/GPP, Pharmaceutical Lab Testing as per USP standards, CMC, QMS, and HACCP Work Experience
Sterile Compounding Specialist Aved Dec 2023 - Present Oshawa, Ontario
● Utilize automation equipment, including pumps, autoclaves, balances, and dry heat ovens, to optimize efficiency and precision in the compounding process, ensuring consistent and sterile pharmaceutical products.
● Skilled in performing sterile technique validations and environmental monitoring of ISO 7 to 5 cleanroom and biological safety cabinet to maintain the integrity and safety of compounded medications.
● Working knowledge of USP <797> and <800> guidelines for sterile compounding, to ensure the sterility and stability of compounded products, proper garbing, hand hygiene, and sterile cleaning protocols.
● Experienced with compounding various dosage forms, including eye drops, syringes, and elastomeric pumps as per USP <797>
● Accurately document batch records, including label reconciliation, lot verification, and documentation of compounding procedures for regulatory compliance.
Advisor General Motor’s May 2019 - Dec 2023
Oshawa, Ontario
● Provided tailored solutions to client issues/concerns in a fast-paced environment through strong problem-solving ability and effective communication skills, achieving 100% client satisfaction.
● Accurately follow and maintain company specific policies: CPNI, PCI compliance etc. resulting in compliance with company and federal regulations.
● Proactively educate self & others on new products, features, & policies helping clients make informed decisions resulting in customer satisfaction
● Effectively communicate and collaborate with other teams/departments about client concerns/requests to find targeted solutions in a timely manner, resulting in client satisfaction Pharmacy Assistant Lovell Drugs Limited Feb 2019 - May 2019 Oshawa, Ontario
● Proficiently use Kroll software to manage patient profiles and fill prescription orders with accuracy
● Accurately prepare 20+ dispills (blister packs) for senior home patients daily to meet weekly deadline schedule
● Inventory management by conducting regular stock checks, ordering medications and supplies, and rotating stock to maintain optimal inventory levels, reducing stock outs by 15%
● Proactively participated in continuing education programs, staying up-to-date with the latest pharmacy regulations and best practices, and maintaining a comprehensive knowledge of pharmaceutical products and drug interactions to better assist patients over the phone Pharmacy Assistant Shoppers Drugmart September 2016 - May 2017 Scarborough, Ontario
● Accurately filled over 90+ prescription orders daily
● Supported the pharmacist in conducting medication therapy management (MTM) sessions, helping patients understand their medications, potential side effects, and compliance, leading to improved medication adherence and patient health outcomes
● Proficiently use Health Watch (patient information management software) to dispense medication and maintain accurate records, resulting in a 99% accuracy rate in medication dispensing.
● Assisted with medication compounding and preparation of specialized dosage forms, demonstrating strong understanding of compounding techniques and maintaining a sterile and safe work environment.
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