Imelda Celestial Email & Phone Number

An enthusiastic and strategic leader in quality assurance, quality control, and compliance within healthcare, medical devices, pharmacy compounding, and the pharmaceutical industry, developing effective systems and high performing teams. I work on building and maintaining strong working relationships across all cross-functional departments, as well as external partners such as Contract Manufacturing Operators (CMOs) and suppliers. Additionally, I steer and foster relationships with Health Canada, the US Food and Drug Administration (FDA), and the National Association of Pharmacy Regulatory Authorities (NAPRA). With a demonstrated capability to assess, drive, and manage change while resolving challenges with knowledge of highly regulatory processes, including GMP environments — some of my interests and main focuses are:• Navigating change with over 20 years of experience in the pharmaceutical industry and GMP regulated environments, including deep experience in leadership and quality assurance management• Expertise in Manufacturing, Quality Assurance, Compliance, R&D, Validation, and Regulatory Affairs• Leading teams to achieve set corporate objectives while ensuring compliance within Canadian and International, as well as US, regulatory guidelines • Strong focus in growing staff to develop and cultivate a high-performing culture • Capability of leading multiple projects for company-wide functions with an experience in change management, risk assessment, and overseeing audits• Ability to oversee changes, deviation/investigations, complaint handling, auditing, risk assessment, cGMP, GLP, CAPA, SOPs, Product Trending, Process Improvement and Development. • Managing resources, budgets, and personnel in sites across the countryThe following qualifications include: ASQ CQA, CQE, CQM/OE, CPGP and, ISO 9001

Listed skills include Quality System, Analytical Chemistry, Laboratory, Pharmaceutical Industry, and 9 others.

• 

  University Of The Philippines

  Chemistry