Senior QA Specialist (High proficiency in English) Are you passionate about working in a global pharmaceutical company that helps people living with allergy?
Are you motivated to make improvements, leading to better economy, quality, and social responsibility?
Are you perceived as a structured and constructive person with excellent collaboration skills?
As a Senior QA Specialist (High proficiency in English), you will provide support for and be directly responsible for a range of Quality Assurance functions.
This position will contribute to ensuring that the performance of manufacturing, packaging operations, and product quality conforms to established cGMPs to ensure lasting customer satisfaction.
This individual will demonstrate a high level of involvement in continuous improvement of the quality assurance philosophy and practice to ensure the right standards are implemented.
Reports to: Quality Support Manager
Fields of responsibility: Perform Quality Assurance activities associated with maintaining internal Quality Systems: Change control, Deviations, CAPA, etc. Review GMP technical and validation reports: Manufacturing and packaging processes. Computer/Automated systems involved in testing, manufacturing, or materials control. Cleaning Validation/Equipment cleaning procedures. Laboratory and manufacturing equipment qualification. Facilities and Utilities with product contact. Analytical methods validation. Provide quality support to technology transfer projects. Provide on-site guidance in the preparation of procedures and working instructions. Assist in providing resolution to GMP issues through identification of problem areas, refinement of systems, training, and coaching of relevant personnel. Help support a permanent inspection readiness status. Provide QA support for regulatory filings. Prepare documentation for Material Review Board presentation and meetings. Support QA Management as required. Provide GMP quality expertise, advice, and/or assistance across the organization as required. Qualifications: Minimum of 5 years' experience in the pharmaceutical/biotech industry with a thorough knowledge of quality systems, GMP, and regulatory requirements. University degree in Chemistry, Pharmacy, Biology, or equivalent. Essential skill: Fluent in written and spoken English. Thorough knowledge of sterile products regulation. Knowledge of oral solids forms and technology transfer projects is valuable. Must have expertise in interdisciplinary areas of pharmaceutical sciences, analytical chemistry, microbiology, cGMPs, regulatory issues, and data integrity regulation. Strong interpersonal and leadership skills in dealing with a variety of cultures on non-routine matters in stressful situations, capable of handling organizational complexity and ambiguity. Ideally, experience in Medical Devices.
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