Client OverviewMy Client specializes in the process development and cGMP manufacturing of biologics and cell therapy products using microbial and mammalian expression systems.
With a commitment to advancing biotechnology, it provides customized solutions for clients in human and animal health sectors, supporting projects from early development to commercial production.Employees are united by a shared purpose of delivering advanced medicines and driving innovations that improve lives.About The RoleThe Quality Assurance Specialist will play a critical role in maintaining compliance with GMP regulations and supporting the organization's quality assurance goals.
This position involves document review, process verification, and collaboration with various teams to ensure the highest standards of quality and compliance.Key ResponsibilitiesCompliance Support: Ensure adherence to GMP standards and the company's Quality System while achieving departmental quality objectives.Documentation Review: Prepare and review deviations, change controls, risk management plans, corrective/preventive actions, OOS, OOT, AMBs, and customer or supplier claims.Audit Assistance: Provide support during client and regulatory authority audits.Verification Processes: Review GMP lot documentation, stability study protocols, and reports, as well as process and cleaning verifications.System Documentation: Manage and issue quality system documentation required for cross-departmental activities.Product Oversight: Prepare product quality reviews and evaluate product specifications.Candidate ProfileThe ideal candidate will bring:Educational Background: A bachelor's degree in Pharmacy, Chemical Engineering, Biochemistry, or a related field.Experience: At least 5 years of experience in quality assurance, with previous exposure to CDMO environments considered an advantage.Expertise: In-depth understanding of GMP regulations.Language Skills: Proficiency in English is highly desirable.What's on OfferThis role provides a supportive environment and numerous benefits designed to promote work-life balance, professional growth, and well-being:Paid Time Off: Enjoy 27 paid days annually, including vacation, personal days, and an additional company-set day off.Flexible Working: Benefit from flexible weekday schedules, reduced hours on Fridays, and special summer hours.Comprehensive Benefits: Access flexible compensation plans, exclusive employee discounts, and relocation support for out-of-region hires.Learning & Development: Receive personalized career plans created by the dedicated Learning & Development team to foster professional growth.Employee Well-being: Participate in programs promoting physical, psychological, and emotional health, including charity events and wellness initiatives.Dynamic Environment: Work in a collaborative setting with flat hierarchies and streamlined decision-making processes.#J-18808-Ljbffr