Quality Assurance Specialist

Career Opportunities: Quality Assurance Specialist (1984) SHL Medical is a world-leading provider in the design, development, and manufacturing of advanced self-injection devices. With a global team of 6,000 employees, we partner with leading pharmaceutical and biotech companies to deliver innovative autoinjectors, pen injectors, and other drug delivery systems that ensure effective treatment for patients. Headquartered in Switzerland since 2018, with key operations in Sweden, Taiwan, and the US, we are united by a commitment to innovation, impact, and growth. Together, we empower our people to develop solutions that make a meaningful difference in the lives of millions of patients while fostering a supportive, inclusive, and dynamic workplace for our colleagues. Job Overview QA Specialist provides oversight of GMP operations to ensure that products are manufactured according to cGMP requirements and fit for their intended use. Maintains data collected from the manufacturing process, generates, and updates procedures and ensures Batch Records comply with established policies and procedures. In addition, QA Specialist will support Design Transfer Activities through product commercialization. Main Responsibilities Review and Approve Production Batch Records and Testing Results to ensure they are complete, accurate and documented according to established procedures. Prepare CofC and CoAs. Maintains QA manufacturing floor presence in support of manufacturing operations and provides oversight over process related decisions. Reviews and approves Quality Work Instructions (QWIs), Technical and Product Specifications, Sampling instructions and Test Methods. Provides oversight to the Design Transfer process with includes deliverables such as Plans, Qualification Protocols, Risk Assessments, Technical specifications, procedures, and process validation documentation among others. Review and approve Test Method Development, Validation, and Transfer activities in support of the Analytical Sciences department. Review and approve Stability Studies protocols and reports. Support the investigation process for Non-Conformances and ensures completion of related corrective and preventive actions. Support the Audit Team with during external and internal audits. Provides support to the program management office with the review and approval of the design transfer package documentation. Provides Quality support for throughout the product lifecycle to include the review of Annual product reviews, Product Process Monitoring activities and Continuous Improvement initiatives. Supporting training of new QA operations team members and serve as a mentor for documentation practices in Quality culture. Skills and Qualification Preferred BS in Engineering, Biology, or other technical related degree A minimum of 4 years of experience in Quality with Pharmaceutical and/or Medical Device based GMP manufacturing operations. Proficient skill in handling multiple responsibilities, tasks and projects simultaneously including ability to shift priorities. Demonstrate proficient ability to evaluate and apply compliance requirements/guidelines to complex situations. Knowledge of regulations and practices pertaining to pharmaceutical/medical device products in area of responsibility 21 CFR Part 11, 21 CFR 210 and 211, 21 CFR 820 and ISO 13485. Ability to interact with regulatory agencies. knowledge of FDA, EMA, JP, HC and other regulations. Knowledge of Good Manufacturing Practices & Good Documentation Practices Able to communicate effectively and work within cross-functional teams. Excellent oral and written communication skills with strong technical writing experience required. Experience in internal / external audits, identify findings, drive resolution, and provide closure report. Proficient skills in solving complex problems and ability to bring issues to resolution. Experience working globally with diverse teams and cultures. We Offer Competitive compensation package Modern working environment with state-of-the-art facilities and technologies Challenging assignments in a fast growing and innovative industry Position in a dynamic, international team of highly skilled professionals Various opportunities for personal and professional development within a global organization Please note that SHL is a drug free employer. This offer of employment is contingent upon your successful completion of various preemployment screenings, including, but not limited to, a drug test, employment verification, reference checks, and a criminal background check. For more information on SHL Medical, please visit: shl-medical.com #J-18808-Ljbffr