天津招聘

The Job

l   Execution of documented assessments of the GMP and Quality Systems compliance status of assigned suppliers.

l   Management of supplier action plans to close identified gaps resulting from said documented assessments.

l   Maintenance of audit and user site data for assigned suppliers in the company supplier management systems.

l   Completion of assigned Supply Chain Risk Assessments for assigned suppliers.

l   Providing support of Quality Assurance Agreement negotiations and supplier change control via assigned tasks for assigned suppliers, as applicable.

l   Performing GMP/Quality System assessments/audits of assigned suppliers within role scope; making a risk based recommendation on the approval status of the supplier (including proposals about the continued use of suppliers with marginal compliance, as applicable) and documenting the assessments/audits in the relevant systems within the targeted timelines.

l   Responsible for agreement of appropriate corrective and preventive action (CAPA) plans with suppliers and follow-up on the completion of agreed CAPAs within agreed timelines.

l   Ensuring that all audit related documentation is communicated out within the targeted timelines and that CAPA related documents are reviewed and responded to within targeted timelines.

l   Responsible for maintenance of “auditee” (supplier) profiles in the relevant data systems and ensuring that all data associated with the supplier assessment and user sites are kept current based on currently available information provided.

l   Collating identified risks and escalating high risk issues/situations to ensure management and stakeholders understand the technical, regulatory and quality risks and that appropriate mitigating actions are identified.

l   Providing relevant support to the company sites undergoing regulatory/customer inspections, as assigned.

The Incumbent

l   Bachelor degree or above in Science (preferably Biopharmaceutical, Biochemistry, Microbiology).

l   Knowledge of / experience in biopharmaceutical manufacturing processes / environments, sterile, parenteral and/or API.

l   Auditor certification from relevant external organization and/or the company auditor certification.

l   Experience auditing a variety of suppliers (preferably biopharmaceutical materials, sterile APIs & services, APIs).

l   Proficiency and experience in planning and executing audits to identify and reduce significant risks / non-compliances.

l   Knowledge of regional/global GMP and the company’s quality requirements and ability to explain these and relate them to the company manufacturing operations and supplier operations, applying good business judgment in doing so.

l   Good spoken and written English skills.

在香港于1991年成立，专门为大中华地区的跨国企业提供全面的人力资源管理顾问工作。其中包括企业管理顾问，高级人才聘用，管理及语言培训，及薪酬福利调查等等。普卓国际顾问由一群于业内享有公认成就的管理人创办，并早于1995在广州成立国内***家分公司。目前除香港总部及加拿大多伦多分公司外，在大中华地区分公司还包括北京，上海, 天津, 深圳, 成都，台北, 澳门等。