北京招聘

Job Description:
-Assure that all areas of the PuraCap facility comply with current Good Manufacturing Practices and that any deviations observed are documented and corrected.
-Define and implement Quality Assurance objectives and strategies.
-Supervise and direct the development and administration of budgets, schedules resources allocation.
-Audit and evaluate vendors/suppliers/CMOs in China and overseas.
-Assist Quality Director in writing & preparing quality and manufacturing SOP and related documents.
-Assure that all PuraCap products are manufactured and packaged in full compliance with FDA regulations, current industry standards, current Good Manufacturing Practices (GMP), and PuraCap SOPs.
-Investigate actual and potential manufacturing packaging problems and providing documented results to the Director of Quality.
-Provide supervision and training to all Quality Assurance department personnel.
-Assure that the requirements of the Master Validation Plan (MVP) are followed by production personnel and that the MVP is reviewed on a bi-annual basis.
-Assure that all vendors used by PuraCap have been appropriately audited and/or approved by Quality Assurance.
-Review batch records to ensure correctness, completeness, and cGMP compliance.

Job Requirement:
-Education: Requires a B.S. or M.S. degree in life sciences or.
-5-7 + years experience in QA or similar function within a pharmaceutical environment. (Substantial pharmaceutical QC experience will be a plus).
-A high level of competence in the day-to-day management of the QA program.
-Performed audits and inspections of studies, programs, processes, and/or quality systems of CMOs to ensure compliance with cGMP regulations, FDA guidelines, and industry standards.
-Worked towards or participated in the development and implementation of QA program.
-Have excellent writing skill required for preparation of regulatory and quality documents.
-Familiar with QC operation is a plus.
-Possess a diversified background with strong technical, business and managerial skills.
-Detail-oriented.
-Self directed and disciplined to achieve anticipated results.
-Strong interpersonal, communication, and negotiation skills.
-Flexibility.
-Proficient in MS Office applications.

        安仕达咨询（Nstarts Consultants）是一家专注于人力资源配置与发展的咨询公司，我们为客户提供专业、精准的猎头服务与RPO服务。

        我们在2004年成立于香港，2005年开始拓展大陆市场，至今已先后在深圳、广州、上海、北京、杭州、长沙、江门成立分公司。运营至今，我们拥有超过10年的人力市场运营经验，为数百家优秀企业提供过人力资源服务。目前，合作3年以上并且愿意与我们建立长期合作伙伴关系的优秀企业已超过200家。

        我们拥有超过100位的专业顾问，他们专注行业发展，为客户提供专业、优质的人力资源服务。我们深入了解客户的需求与文化，了解候选人的能力与动机，为客户与人才提供***匹配方案。

        如需了解更多信息，请浏览公司主页：www.nstarts.com。

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-安仕达的快速而稳健的发展，可为你带来更多的学习机会和上升空间。
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