Company Overview:
Asymchem is a leading global CDMO with over 25 years of experience supporting top pharmaceutical and biotech companies in advancing new therapies from early development through commercial production. With eight R&D and manufacturing sites, a team of 9,700+ professionals, and a strong regulatory track record, we bring deep technical expertise and unwavering commitment to quality.
Duties & Responsibilities:
- Organizing, coordinating, to execute the quality assurance actives during the manufacturing of product and running of the quality system.
- Perform daily/weekly/monthly on-site inspection and reviewing on the operation area, operation and behaviors, document and record during the product manufacturing。
- Review the product release documentation and other quality system documentation, ensure the production and testing of each lot of released product meet the regulatory requirement, regulatory filing, pre-defined process and product spec.
- Review and/or approve minor or major change within the responsible range.
- Review and/or approve the minor, major or critical deviation within the responsible range. Participate the investigation on critical deviation and customer complaint, analyze the root cause and propose effective CAPAs.
- Approve other quality related documents as specified in the related SOPs for project management.
- Participate in the annual QA internal audit plan, organize the periodically walk-through, and report the results.
- Organize and participate in the preparation for readiness of plan for customer QA audit/regulatory inspection, participate in the customer QA audit/regulatory inspection, propose reasonable and effective action plan on the observations, follow-up the implementation on CAPAs.
- Review and approve master batch records and executed batch records to assure compliance with regulatory standards and regulatory filing.
- Be responsible for other tasks assigned by the superior.
Experience Requirements:
- Master's degree and 5 years of quality assurance in the biotechnology or pharmaceutical industry.
OR - Bachelor's degree and 10 years of quality assurance in the biotechnology or pharmaceutical industry.
- Experience in pharmaceutical environment, Good Manufacturing Practices (GMP) and the applicable GxP regulations and standards.
- Knowledge of corporate quality systems that are applicable to the quality unit and the production operations service.
- Effective communication and interpersonal skills.
- Demonstrated experience in Microsoft Office tools.
- English as working language.