L’entreprise
Would you like to be part of an exciting journey that combines growth, innovation, and health?
In an environment that merges the strength of a cutting-edge industry with the agility of a start-up?
Join us!
A pioneer in the bacterial fermentation of hyaluronic acid, HTL Biotechnology is now the global leader in the development and sustainable production of innovative pharmaceutical-grade biopolymers.
Our mission is to unlock the potential of biopolymers to improve health, quality of life, and well-being for patients around the world.
By 2030, our biopolymers will benefit more than 500 million patients suffering from eye diseases, rheumatologic conditions, and skin aging.

EXPERIENCE, SKILLS & KNOWLEDGE :

• Bachelor’s Degree in a relevant scientific discipline preferred with a minimum of 7 years of biotech industry experience with 4+ years of experience in a QA role supporting late stage clinical and/or commercial production.
• relevant experience in GMP manufacturing, specifically batch record reviews, along with batch and raw material dispositions, review of equipment validation/qualification documentation, review of calibration/maintenance documentation, and experience writing/reviewing quality systems documentation.
• Experience developing training documentation, work instructions, and OJTs. The ideal candidate should have relevant experience in Quality Assurance, CGMP compliance, and enjoy fast-paced, collaborative, and vibrant startup culture.
• Experience performing RCA, technical writing, and working with quality related investigations
• Knowledge of laboratory and production equipment and IQ/OQ/PQ - CFRs, CGMP, and EU Regulatory requirements.
• Experience developing and implementing all aspects of a robust QMS.
• Ability to work in a fast paced work environment.
• Ability to work effectively with others in a team-oriented environment and independently when needed.
• Ability to adapt to changing priorities.
• Ability to work with precision and thoroughness/detail-oriented.
• Possesses good organizational, communication and technical writing skills.
• Travel to Vendors/Suppliers to support audits.
• Able to translate ideas to actual concepts and processes.
• Able to work in a highly complex environment with competing demands and priorities.

The Sr. QA Specialist ensure the quality of products and compliance to internal procedures and external standards.

• Perform review of batch documentation for release of bulk drug substance, while ensuring compliance with CGMPs, site SOPs, and regulatory requirements. Prioritize record review in support of business needs including maintaining batch status and communicate release needs throughout the organization.
• Review and approve master batch records for the timely initiation of GxP manufacturing activities.
• Responsible for quality oversight and administration of the deviation/investigation and CAPA programs.
• Review and approve Manufacturing, Quality Control, and other investigations in support of batch release.
• Provide direction for complex investigations and CAPAs.
• Ensure timely, accurate and complete execution and documentation of quality system events: deviations, investigations and CAPAs.
• Review, develop, and improve quality system procedures/Review and approve CAPAs to prevent recurrence of deviations.
• Review and approve Change Control documentation.
• Monitor, identify and propose quality process and system improvements. Lead improvement projects and communicate status to management.
• Serve as QA representative to cross functional project teams such as tech transfer, process validation, and process improvement.
• Review and approve master batch records for the timely initiation of manufacturing activities
• Perform review of batch documentation for release of internal and external clinical. products/commercial products, while ensuring compliance with CGMPs, site SOPs, and regulatory requirements. Prioritize record review in support of business needs including maintaining batch status and communicate release needs throughout the organization
• Provide training on department specific procedures and systems.
• Initiate, revise, and review controlled cGMP documents including SOPs, Material. Specifications, Investigation protocols/reports, validation protocols/reports as applicable
• Ensures site readiness for regulatory inspections.

Profil recherché