Umar Khalid Email & Phone Number

Calgary, Ab, Ca

Alberta, Canada

Regina, Saskatchewan, Canada

 Providing immediate containment, trace, and risk assessments for deviations in the QMS program, donor, and blood/plasma safety concerns, and GMP issues during daily operation internal, external, and regulatory audits. Generating responses to audit exit notes and / or final reports. Completion of all response associated tasks well within timelines. Assisting end-users of electronic QMS & CCP by providing training on use of software and procedures. Liaise with all departments to… Show more  Providing immediate containment, trace, and risk assessments for deviations in the QMS program, donor, and blood/plasma safety concerns, and GMP issues during daily operation internal, external, and regulatory audits. Generating responses to audit exit notes and / or final reports. Completion of all response associated tasks well within timelines. Assisting end-users of electronic QMS & CCP by providing training on use of software and procedures. Liaise with all departments to ensure timely and appropriate disposition of product in response to SOP and/or CCP deviations. Including writing in depth risk assessment reports for management review and approval. Maintaining flow of documentation in electronic and physical QMS through ongoing layered audits of records and monthly results summary on QMS findings, utilizing SAP, SharePoint, and Excel software to generate reports of the successes, failures, RCA & CAPA for each event, as well as long-term trends for upper-management and stakeholders. Working with cross functional teams for validation activities associated with new equipment, processes, or system upgrades. Exemplified in responding to increased customer complaints of audit-based deviations, including identifying root causes, and developing and monitoring the CAPA’s. Resulted in the implementation of more rigorous workflow programs, increasing internal ability to decrease routine deviations. The head office noticed the related number of deviations and complaints significantly decrease as a direct result of my appointment in the center. Working within the current GMP and Health Canada guidelines and adhering to all regulatory standards within the Company. Ensuring that all aspects of local manufacturing plasma operations are performed according to company standards. Maintain proper records and documentation that complies with GDP/GMP/GLP guidelines and internal Standard Operating Procedures and ensure they are easy to access. Show less

Calgary, Alberta, Canada

General Quality Assurance:Encompassing control of quality-related documentation, assistance in document creation and review, equipment management, adherence to regulatory standards, and data analysis for trend identification and corrective action planning.Deviations/Non-conformances:Preparation of deviation reports, determining root causes, designing Corrective and Preventative Action Plans, and ensuring timely completion of actions across various… Show more General Quality Assurance:Encompassing control of quality-related documentation, assistance in document creation and review, equipment management, adherence to regulatory standards, and data analysis for trend identification and corrective action planning.Deviations/Non-conformances:Preparation of deviation reports, determining root causes, designing Corrective and Preventative Action Plans, and ensuring timely completion of actions across various departments.Auditing:Assisting internal and external audits conducted by authorities or customers, aiding in designing action plans, preparation of audit reports and non-conformance reports, ensuring proper documentation, and timely closure of all audits.Training:Responsible for training center staff and others on SOPs, policies, corrective actions, software usage, GMP, and ISO guidelines; perform QA review of training records, assist in conducting training programs, and may coordinate training for new center-specific employees.Production / Quality control Conduct inspections of incoming materials, reporting any defects to the Quality Systems Manager; monitor Environmental Monitoring System reports weekly; assist in ensuring product shipments meet quality requirements, are accurately labeled, and shipped to testing laboratories; and support equipment or process validations for the center. Show less

Calgary, Alberta, Canada

Faisalabad, Punjab, Pakistan

 Supporting cross-functional teams when issues arise in adherence to GMPs, FSQA procedures and processes. Providing refresher trainings and coaching to plant personnels as needed, evidenced by the plant’s AA rating during the years of employment. Including the internal launch of X-ray CCP documentation for SAP software, trained operators and provided feedback to process owners when revision may be required to ensure successful process roll-out and compliance. CoA review and approval… Show more  Supporting cross-functional teams when issues arise in adherence to GMPs, FSQA procedures and processes. Providing refresher trainings and coaching to plant personnels as needed, evidenced by the plant’s AA rating during the years of employment. Including the internal launch of X-ray CCP documentation for SAP software, trained operators and provided feedback to process owners when revision may be required to ensure successful process roll-out and compliance. CoA review and approval of incoming ingredients in key metrics. Initiating Supplier Non-Conformance Reports to receive replacement for products outside of the required and established specifications. Performed standardized quality control tests which include the following: sensory, allergen assays (peanut/nut, gluten, dairy), microbial and compositional analysis (including fat extraction analysis and plate reading), environmental and allergen swabbing, environmental sampling, packaging compliance inspections, weight and volume checks, and sanitation validation. Promoting GMP compliance across the organization by performing internal GMP audits for quality and safety concerns in all areas of the production and the storage facility. Reviewing periodic product data, and collaborating with production, commercial, and senior leadership teams to improve product specification targets and accuracy. Lead annual plant-wide refresher training on quarterly FSQA topics. Show less

Faisalabad, Punjab, Pakistan

 Liaising with faculty staff and other colleagues Supervising a team of Master's students. Helping principal course instructor in gathering updated data for Lectures.Evaluation of student performance, including grading exams, quizzes, assignments, and papers. Meeting with the course instructor and assisting in determining grading criteria, planning, scheduling, and facilitating the review sessions for exams as requested by the students. Participated in writing and editing of… Show more  Liaising with faculty staff and other colleagues Supervising a team of Master's students. Helping principal course instructor in gathering updated data for Lectures.Evaluation of student performance, including grading exams, quizzes, assignments, and papers. Meeting with the course instructor and assisting in determining grading criteria, planning, scheduling, and facilitating the review sessions for exams as requested by the students. Participated in writing and editing of several student assignments and teacher's resources along with the evaluation of student’s performance, including grading exams, quizzes, assignments, and papers. Helped curate a curriculum of experiment-based lessons on the fundamentals of Microbiology. Managing day-to-day operations of the laboratory experiments and guiding students in wet lab experiments including DNA extraction, yeast fermentation, bacterial culturing, PCR, and pathogenic virus isolation via tissue culturing (in BSL-3 Lab). Collaborating with faculty, colleagues, and students, utilizing effective communication skills, acts of kindness, connections fostering skills along with trust, and mutual respect to foster strong student-instructor relationships. Show less

Faisalabad, Punjab, Pakistan

 Making sure that everyone is working within the current GMP and PHC guidelines and adhering to all regulatory standards and SOPs within the pathology lab department. Ensuring that all aspects of testing and operations are being performed completely and according to company standards and results reporting is being completed within TATs. Ensuring that safety regulations are always followed and maintaining a clean and safe work environment. Served as onsite technician for external… Show more  Making sure that everyone is working within the current GMP and PHC guidelines and adhering to all regulatory standards and SOPs within the pathology lab department. Ensuring that all aspects of testing and operations are being performed completely and according to company standards and results reporting is being completed within TATs. Ensuring that safety regulations are always followed and maintaining a clean and safe work environment. Served as onsite technician for external vendors performing equipment maintenance and calibrations and maintaining laboratory equipment records etc. Helped reviewing standard operating procedures and participating in proficiency testing, and internal and external audits. Building relationships and interacting with patients to address any of their curies in order to provide excellent services and consultation. Maintenance of laboratory supplies inventory by checking stock to determine inventory level, anticipating needed supplies; placing and expediting orders for supplies; verifying receipt of supplies. During this position, I also performed duties in the Covid testing Bio Safety Level 3 lab. In the early days of the Covid outbreak, my responsibilities also included training the staff regarding all the latest guidelines and performing covid PCR testing for suspected patients and international travelers under a very high workload environment. Show less

Faisalabad, Punjab, Pakistan

 Day-to-day duties included the processing of samples for extraction of DNA/RNA, proper documentation, sample storage procedures, and performing various laboratory activities in the Molecular and Microbiology lab. Performing PCR for the presence of certain viruses such as Hepatitis B, C, and HIV etc., and some other immunological assays such as T. Spot TB testing for Mycobacterium Tuberculosis. Operation and maintenance of lab equipment such as real-time PCR machines, and… Show more  Day-to-day duties included the processing of samples for extraction of DNA/RNA, proper documentation, sample storage procedures, and performing various laboratory activities in the Molecular and Microbiology lab. Performing PCR for the presence of certain viruses such as Hepatitis B, C, and HIV etc., and some other immunological assays such as T. Spot TB testing for Mycobacterium Tuberculosis. Operation and maintenance of lab equipment such as real-time PCR machines, and routineequipment including spectrophotometers, centrifuges, micropipettes, autoclaves, biocontainment hoods, etc. Detection, isolation, enumeration, and identification of microorganisms using a wide variety of molecular, morphological, and biochemical tests, serological procedures, and other specialized techniques. Recording results and lab data in hard copy and in electronic databases ensuring the acceptance of data by meeting requirements of quality control testing and presentation summaries of results for review by the lab scientist. Maintaining professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; participating in professional societies. Show less

Master'S Degree, Clinical Microbiology And Bacteriology (Credentials Assessed By Wes & Iqas)

B.Sc. (Hons.) Clinical Microbiology (Credentials Assessed By Wes And Iqas)

High School Diploma (Credentials Assessed By Wes & Iqas), Pre-Medicine/Pre-Medical Studies