| Candidate Information | | Title | Product Development Quality Assurance | | Target Location | US-NJ-Irvington |
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Click here or scroll down to respond to this candidateProfessional SummaryA seasoned professional with over 7 years of expertise in Quality Assurance, Regulatory Compliance, and Product Development. Proven track record in formulating effective QA strategies, ensuring compliance, and driving process optimization. Seeking opportunities for impactful contributions in a dynamic work environment related to access to healthcare services or health products.EducationThe College of New Jersey, Ewing, NJ Expected May, Street Address
Master of Public Health (MPH), Epidemiology and Health AnalyticsGraduate Student Organization, President, September Street Address to September 2023University of The Punjab, Lahore, Pakistan October 2011 to November 2016University College of PharmacyDoctor of Pharmacy (Pharm. D)University of The Punjab, Lahore, Pakistan January 2013 to March 2015Additional Studies along with Pharm. D to qualify for a BSc degreeBachelor of Science (BSc)Professional ExperiencePolicy Data Analyst, Community of International Neonatal Nursing (COINN), USA February 2023 to December 2023Co-authored the manuscript 'Neonatal Nurses: A Missing Link in Neonatal Mortality Outcomes,' currently under review for publication in the International Journal of Environmental Research and Public Health, highlighting contributions to advancing knowledge in neonatal care and mortality reduction strategies.Selected to present two abstracts, 'Unveiling Kangaroo Mother Care Practices: Insights from Healthcare Providers' and 'Improving Neonatal Mortality Outcomes: A Quality Improvement Initiative Assessing Teaching Approaches for Nurse Practitioners and/or Healthcare Trainers,' at the prestigious COINN 2024 conference in Denmark, showcasing expertise in neonatal care research and quality improvement initiatives.Actively engaged in Community of Neonatal Practice (CoNP), a Bill and Melinda Gates Foundation-funded initiative, advocating for enhanced neonatal care across Africa through weekly meetings focused on new launches and related initiatives.Led a Quality Improvement Project in collaboration with CoNP to evaluate teaching methods for neonatal care, aligning with the WHO's HRH Roadmap to reduce neonatal mortality rates.Authored a publication on the CoNP website for awareness and support of iKMC (Kangaroo Mother Care), following the release of the WHO 'Born Too Soon' report. CoNP Blog - https://www.conpcommunityofpractice.org/post/kangaroo-mother-care-kmc-to-the-rescueHead RND Global Markets and Regulatory Affairs January 2020 to January 2023DRK Pharma Solutions GmbH, SwitzerlandInstrumental in implementing new systems that drove a substantial revenue increase to $13.4M through enhanced service offerings and accelerated Product Development Services.Generated over 70 essential documents and systems at DRK, spanning Lab-scale Product Development, Formulation Optimization, Analytical Method Development, and end-to-end Product Development across diverse dosage forms, ensuring alignment with DRK's operational models.Spearheaded new product development and tech transfer, ensuring regional regulatory compliance.Demonstrated proficiency in drug formulation, process scale-up, and tech transfer.Prepared and submitted Abbreviated New Drug Applications (ANDAs) with a strong grasp of regulatory standards.Directed a team of 15 scientists and project monitors, ensuring precise project execution and on-time delivery. Spearheaded strategic product development endeavors for a diverse clientele across Malaysia, Italy, Greece, the UK, and other regions, including successful technology transfer projects in MalaysiaHead RND Global Markets & Corporate Compliance (GxP) April 2017 to January 2020Remington Pharmaceutical Industries, Lahore, PakistanLed comprehensive product development and validation processes, ensuring compliance with quality standards and regulatory requirements. Successfully achieved WHO Prequalification for a key pharmaceutical product, contributing to enhanced healthcare access and global recognition.Guided product development across clinical phases, ensuring quality and regulatory compliance.Led cross-functional discussions, managed quality agreements, and oversaw cGMP compliance.Played a pivotal role in process and technology transfer risk assessments.Achieved historic WHO Prequalification for Remington and gained recognition for the Levofloxacin tablet.Participated in WHO PQ training workshops to stay abreast of regulatory expectations. Presented QIS and QOS to the WHO PQ assessment team, and facilitated a successful audit by inviting the WHO Inspection team to post-site readiness and preparation at Remington.Pioneered innovative systems for documentation and facilitated their transfer to other companies.CertificationsMIT Sloan Artificial Intelligence in Pharma and Biotech, MIT, Boston, USA, (July 2023)Exploring Cross-Cultural Communication - University at Albany School of Public Health, New York, USALahore University of Management Sciences, Lahore, Pakistan, (Jan 2020 to Feb 2020)Centre for Continuing Education StudiesPublic Speaking CourseHealth Literacy and Public Health - University at Albany School of Public Health, New York, USAAwardsExceptional Impact Award (PKR 1 million) - Remington Pharmaceutical Industries, (2023)Massachusetts Institute of Technology (MIT), Boston, USA, (May 2023 to July 2023)Sloan Artificial Intelligence in Pharma and Biotech CoursePresented Manufacturer's Perspective at ACT Accelerator Facilitation Council 10th Council Meeting (Apr 2022)Interview Published on MPP Official Site: A Lasting Alliance to Ensure Equitable Access to Affordable Medicines - MPP (medicinespatentpool.org)WHO Prequalification Success - Gold Medal (PKR 1 million) - Remington Pharmaceutical Industries, (Sep 2021)Honorable Team Member for WHO PQ Project Leadership - Remington Pharmaceutical Industries, (Sep 2021)Technical SkillsQuality Assurance and Regulatory Compliance as per the relevant regulationsProduct Development ICHQ8R2, US FDA, WHO, EMA, MHRARegulatory submission like CAPA reports, CTDs, monthly updates in inspection report responseCAPA writing, Quality Risk Management, Change Control, Root Cause AnalysisProtocol creation, SOP writing, Qualification, and Validation documents preparationMock Inspection and Quality AssuranceMicrosoft Office Suite (Excel, PowerPoint, Word)Data analysis software (R Studio, SAS and SPSS)Data Collection tools (SurveyMonkey, Qualtrics, Google Form) |
