南京招聘

Accountabilities:

Manage the scheduling and planning of the annual quality audits of suppliers (+CMOs, etc) effectively

The schedule and plan of supplier audit is created and managed based on cost, time, and resource efficiency.

? Prepare supplier audits and collect information from internal and external sources

? Align audit focus and audit depth with BI OPUs in the delegation system

? Perform delegated supplier audits on behalf of all BI OPUs or Corporate Division SQE for APIs, excipients, packaging material, intermediates, starting materials, contract manufacturer, etc, according to a pre-defined plan to assess the quality systems and the GMP (or other standard/regulations) compliance level of suppliers

? Identify risks and assign risk categories for the deficiencies observed

? Communicate risks resulting from BI suppliers

? Document audit results in audit reports

Manage the supplier's CAPA (Corrective Action and Preventive Action) to ensure timely closure

CAPA's of supplier is managed, tracked, followed-up, and closed to meet a specific percentage rate target:

? Review and assess adequacy of corrective/preventive action plans of suppliers

? Monitor the completion of corrective/preventive action plans

? Trend audit findings and identify areas for improvement

? identify and share best practice

Manage the list of suppliers in China

An accurate suppliers list is maintained and updated on a periodic basis, posted, and archived.

Manage and support interactions with other relevant BI business units or functions

Include the communication and interactions of other business units (e.g., OPUs) in related activities (e.g., pre-Audit planning, supplier acceptability decision making, etc.).

Collaborate on projects with other BI businesss units or functions (e.g., GQS, SNQM, SBS, etc.) as determined by the group's director,

Perform risk management and routine surveillance of suppliers

Develop and manage supplier risk management program, including (but not limited to):

? Conducting risk assessments and perform gap analysis

? Identifying risk mitigation strategies

? Perform market surveillance and provide critical informatio and report suspicious incidents and potential shortages to the BI network

? Developing proactive measures to prevent negative consequences for BI

Conduct periodic surveillance and communicate relevant information (pertaining to the suppliers) to the appropriate parties within the BI global network:

Periodic surveillance is performed to include suppliers, regulatory, and general industry news/events related to the group's operation.

Develop and build inter-relationship with suppliers, regulatory authorities, and other pertinent parties to enhance quality awareness and practices

Perform annual supplier training program to Support suppliers with cGMP, GDP and quality systems know how and to promote compliance with cGMP, GDP

Perform periodic round table discussion with the industry and regulatory authorities.

Participate in professional organization and events.

Participate and manage individual goals and development plan

Ensure MAG (annual goal setting) and individual development plan that is agreed with the group's director are in place and performed.

Skills & Competencies Requirement:

? Bachelor degree or higher from an accredited university

? Preferred Science (e.g., Chemistry, Pharmacy) or Engineering (e.g., Chemical Engineering)

? Minimum 5 years of working experience in a pharmaceutical GMP environment with some auditing experience.

? Expert knowledge of domestic and international regulations regarding Good Manufacturing Practice (GMP) and Good Distribution Practice for Active Pharmaceutical Ingredients (APIs) and pharmaceutical products (GDP).

? In-depth knowledge of Quality Systems and related norms (e.g. ICH 8/9/10, ISO 9000 series).

? Well verse in spoken and written English language, as well as a native Chinese language capability.

? Willing and able to travel at least 50% of the time.

? Skillful in using office application software (MS-Word, MS-Excel, MS-Outlook)

? Dispute resolution and decision making skills

? Inter-cultural competence

? Keep up to date with the regulatory requirements pertinent to GMP and/or other regulatory matters affecting the responsibility described above.

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