招聘人数:1 人
性别要求:不限性别
Job Description:Build the internal quality compliance audit program & Qualified auditor group. Ensure the alignment and adherence to the global quality system across sites via internal audit.Independently lead/participate on GMP compliance audits and identify GMP compliance gaps or risks. Provide GMP compliance expertise to internal customers. Perform tasks and work to achieve company goals and organizational objectives. Lead and Participate in audits which include preparing the audit plan/agenda, conducting the site audit, developing audit report to address the individual gaps and system gaps. Follow up the remediate action for the findings, including evaluation of the response from the internal customers for identified audit findings. Identifies gaps/risks in corporate practices, policies and procedures and prioritizes based on current regulatory environment, guides and regulations. Tracking the regulatory inspection trend, e.g. reviewing FDA-483 observations, EIRs and audit findings &Working with the data analysis team to analysis the internal compliance data analysisSupport the team leader to set 4. up the internal quality compliance audit program including procedure/plan/audit aide memories/report template, etc. 5. Participates in response development to regulatory inspection observations if necessary. Author responses if assigned. Acts as a SME for corporate internal audit team. 6. Participate as an internal compliance team representative in relative meetings to communicate with the stakeholders the compliance status, e.g. communicate the compliance issues/risk with the team, provides input on issues discussed of resolution, etc. 7. Act as the trainer to site internal auditors. 8. Set personal performance goals and provide input to departmental objectives. 9. Perform any other tasks as requested by management to support quality oversight activities.
Qualification:Bachelor/Master degree and above.Major in life science, biology or biochemistry is preferred.With 5 years of experience in QC or product development or process in biotech product.With more than 15 years quality management, compliance or other relevant experience in sterile drug manufacturing.With the experience of corporate quality audit of sterile/bio- product is preferred.With consolidate knowledge of the GMP regulations (CFDA/ EMA /FDA/ICH, etc.) and guidelines.Good communication and coordination skills both in oral and written.With fluent oral English and good English listening, reading and writing ability. Familiar with the operation of quality management software (e.g. trackwise, e-doc) and office software.
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