Associate Director, Authorized Person & Quality APAC, CTS&L
Parexel International Corporation
China - Any Region - Home Based
As required by the Drug Administration Law of the People's Republic of China, Chinese GMP guidelines and/ or Parexel needs, all Medicinal Products and Investigational Medicinal Products (IMPs) must be certified by a Qualified Person (QP) prior to release for use in a Clinical Trial.
• The responsibilities of the Qualified Person include that
o Each batch of investigational medicinal products manufactured in or imported into China complies with the requirements set out in Drug Administration Law of the People's Republic of China and shall certify that those requirements are fulfilled.
o Medicinal products manufactured within China have been manufactured and checked within the boundaries of national law and the requirements of the Marketing Authorization (MA) or Clinical Trial Application for IMP.
o Product imported into the China was manufactured and tested according to CN-GMP and Drug Administration Law of the People's Republic of China. The Qualified Person has to personally convince himself by audit that the IMP was produced according to CN-GMP and the Clinical Trial application (IMPD).
o Critical quality attributes of each IMP to be handled by the QP are understood and that the QP has sufficient knowledge about each IMP to perform the batch release.
o Batch certification is recorded in a register or equivalent document.
o Batch certification is only performed after confirmation that each production batch was manufactured and tested according to CN-GMP.
o Delegation of any QP-tasks is performed only to another Qualified Person(s).
o Release of Investigational Medicinal Products (IMP) is performed according to clinical trial regulations, in accordance with agreed protocols, the principles of International Conference Harmonization, Good Clinical Practice and Good Manufacturing Practice.
o Guidance on technical and regulatory requirements for the conduct of clinical trial is given, as well as advice on GxP-issues.
o A Quality Management System is in place that safeguards that correct procedures in the process for assembly and supply of study medication (investigational medicinal products) are followed.
o A Quality Management System is in place that safeguards that Quality Control procedures are in place and followed.
o Internal and external audits are assisted including supplier qualification audits (e.g. supplier providing starting materials for production activities).
• Accountability Supporting Activities
o Establish easy to follow release procedures which provide a consistent, secure, structured approach that has been repeatedly satisfactorily reviewed during regulatory agency inspections
o Keeping up to date with current regulatory guidance and expectations and proactively ensuring continued compliance by advising customers of the requirements
o Perform auditing of third-party manufacturing, testing, packaging and labelling facilities as required
o Responsible for QP certification and documentation in a register or equivalent document maintained by the QP
o Ensuring that documentations of the receipt, storage and drug distribution of Medicinal Product are in accordance with GDP-and GMP-guidelines
o Assisting the creation of Master Batch Records and procedures for provision of guidance / input into set up of assembly activities of Medicinal Products and ancillary materials as required
o Participation in investigations of quality issues / deviations arising from assembly activities at CNDC or facility (IMP assembly / and storage areas)
Qualifications• Language Skills
o Chinese fluent (written and oral)
o English fluent (written and oral)
• Knowledge and Experience:
o Experience with PDA, TR, ISPE, PIC/S and ICH etc.
o Experience with CFDA GMP, EU GMP, FDA and cGMP.
o Experience with CN QP certification and release of medicinal products and IMP
o Experience with Import & Export of pharmaceutical products
o Experience in Quality Control, Quality Assurance, Quality Systems, Quality Compliance and Quality Improvement required
o GMP / GCP auditing experience
o Regulatory Inspection experience
o Managerial Experience
o Six Sigma LEAN Green Belt or above
o Leadership/Project Management/Technology/Business Operations experience, as appropriate, required
o Fulfilment of qualification as per Drug Administration Law of the People's Republic of China (as interpreted by local Chinese authority in Suzhou China)
o University degree, major in pharmaceutical, chemistry, biology or equivalent related subjects that allows to be Qualified Person according to Drug Administration Law of the People's Republic of China
o Practical experience over a period of at least ten years, in one or more companies authorized to manufacture medicinal products in China, covering qualitative and quantitative analysis of medicinal products
o Prefers licensed pharmacist according to local Chinese regulation in Suzhou, China
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