Regulatory Compliance Expert

vor 3 Wochen

ValdeTravers District, Schweiz WuXi AppTec Vollzeit
Job Summary

We are seeking a highly skilled Quality Assurance Specialist to join our team at WuXi AppTec. As a Quality Assurance Specialist, you will play a critical role in ensuring the compliance of our processes and products with cGMP regulations.

Key Responsibilities
  • Support the design of Master Batch Records for bulk or packaged commercial drug products, ensuring adherence to cGMP guidelines.
  • Review and approve executed batch records and associated QA samples, including API, raw materials, bulk, semi-finished, and finished products.
  • Ensure compilation and archiving of documentation for compliance to GMP as appropriate, maintaining accurate and up-to-date records.
  • Handle deviations, complaints, and CAPA related to our site, ensuring the execution and follow-up of escalation processes.
  • Collaborate with partners on GMP activities, fostering strong relationships and ensuring seamless communication.
  • Develop, revise, and recommend SOPs and quality documents for the Quality department and supported departments, ensuring alignment with company policies and regulations.
  • Review and support the execution of qualification and validation documentation for QA review of relevant documents/reports, including DQ, IQ, OQ, PQ, Cleaning Validation, and Process Validation.
  • Support during Authorities inspections and internal audits, providing expert knowledge and guidance as needed.
  • Represent QA within departments and cross-functional project teams, ensuring effective communication and collaboration.
  • Contribute to recommendations for continuous improvements in Quality systems, identifying areas for enhancement and implementing changes as needed.
  • Regularly report quality process metrics, providing insights and analysis to inform business decisions.
  • Ensure that all regulations concerning product security and established working methods are respected within the area of responsibility, maintaining a culture of compliance and integrity.
Requirements
  • Good understanding of cGMPs and Swiss, EU, and FDA regulatory requirements, with the ability to apply this knowledge in a practical setting.
  • Good understanding of Solid Oral Dosage from packaging and warehousing, or bulk and QC processes, with the ability to analyze and improve these processes.
  • Excellent interpersonal, collaborative, and organizational skills, with the ability to work effectively in a team environment.
  • Ability to work independently and effectively, with a strong sense of responsibility and reliability.
  • Strong written and oral communication skills in both French and English, with the ability to communicate complex information in a clear and concise manner.
  • Very good investigational and QA problem-solving skills, with a keen eye for Quality and the ability to make proposals and facilitate decision-making when escalation is needed.
  • Ability to focus attention to details and handle multiple tasks, working against deadlines and prioritizing tasks effectively.
  • Collaborative, organizational, sense of responsibility, reliability, team spirit, initiative, and service, with a strong commitment to excellence and customer satisfaction.
  • Knowledge of most common office software, with the ability to learn and adapt to new systems and tools.

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