CSV & ERES Compliance Director
- Automation and CSV for WuXi Biologics in general and the Wuxi Bio MFG2 facility in particular.
- Establishing ERES and CSV/computerized system ERES compliance part of QMS (QM part, QSGs, SOPs and CSV validation/compliance documents).
- Working closely with QA, QC, MFG/FFF, ENG, Operation and IT to achieve and maintain Computerized Systems and ERES compliance.
- Lead and act as the key contact person / SME for all issues related to Computerized Systems and ERES compliance during routine quality operation, internal/external audits, health authority (HA) inspections and client communication.
- Serve as a Computerized System Validation Subject Matter Expert and provide strategic guidance. Determine and establish validation requirements for computerized systems based on SOPs and regulatory standards (FDA, EMA) to ensure compliance and maintain an inspection ready state.
- Lead the development of system specific validation plans and strategy using a risk-based approach.
- Provide (modular) training of validation engineers and / or consultants to effectively produce validation deliverables following CSV SOPs and FDA 21CFR Part 11 requirements.
- Provide regular updates related to key accountabilities and scope of the job to senior
- Ensure quality of CSV deliverables for regulated systems and quality of non-regulated systems.
- BS in Engineering, Computer Sciences, or related field.
- At least 10 years of working experiences in the field of computerized system validation in the pharmaceutical industry. Additionally, have more than 5 years of working experiences in engineering fields.
- An expert in related regulatory requirements and industry standards, such as 21 CFR Part 11/210/211, Annex 11 of EU GMP, GAMP 5, ICH Q9/Q10.
- Proficiency in: Trackwise, SAP, LIMS, MES, DCS, Empower, automation, and other pharmaceutical IT systems; Data Management Systems.
- Proficient speaking and writing in English. Having similar skills in Chinese is a plus. Excellent technical writing skills in English is required.
- Excellent training skills for providing both classroom training and on the job training of CSV and ERES compliance.
Department: Process Engineering & Validation
Primary Location: Wuxi, China
To apply please send your application to HR_Biologics@wuxiapptec.com.