武汉招聘

A.POSITION SUMMARY:

Responsible for planning and implementing the activities of Quality Control to ensure the achievement of projects and goals. Monitors and evaluates completion of tasks and projects. May develop budgets for capital expenditures and labor. Typically participates with other managers to establish company policies. Serves as a project champion in areas of expertise. Position requires minimal guidance and direction.

B. MAJOR DUTIES/RESPONSIBILITIES:

·Understand FDA current Good Manufacturing Practices.

·Define and implement Quality Control objectives and strategies.

·Supervise and direct the quality control department in personnel development, administration of budgets, and schedule/ resource allocation.

·Audit and evaluate vendors/ suppliers/ CMOs in China and overseas.

·Assist Quality Director in writing & preparing quality and manufacturing SOP and other related documents.

·Trouble shoot laboratory technical issues.

·Strong hands-on experience in handling corrective and preventive actions.

·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 prevent potential manufacturing and packaging issues, and prepare proper investigation reports

·Provide supervision and training to all Quality Control department personnel.

·Assure that all vendors used by PuraCap have been appropriately audited and/or approved by Quality Control.

·Review laboratory records to ensure correctness, completeness, and cGMP compliance.

·Strong English command in writing, reading, and speaking

C.Education:

Requires a B.S. or M.S. degree in life sciences

D.Experience:

· 5-7 + years experience in QC or similar function within a pharmaceutical environment. (Substantial pharmaceutical QC experience will be must)

· A high level of competence in the day-to-day management of the QC 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 QC program.

· Have excellent writing skill required for preparation of regulatory and quality documents.

· Familiar with QC operation is a must.

E.PHYSICAL DEMANDS/ENVIRONMENTAL CONDITIONS:

Laboratory, plant and office working environment

人福普克药业（武汉）有限公司是设在美国新泽西州的普克医药公司(PuraCap Pharmaceutical LLC)引进美国***制药技术和美国FDA CGMP质量标准，在武汉生物医药产业园投资建立的高质量的国际制药企业，产品涵盖多种剂型的美国处方药/非处方药，面向欧美主流市场。 本公司具有世界级的管理团队和技术力量，有良好的企业文化和发展前景，提供专业培训和有竞争力的待遇，诚邀有志制药行业发展的各位英才加盟，共同打造世界级制药企业。

公司将提供优厚的福利待遇：
薪酬：有竞争力的薪酬（含绩效奖金及年终奖金）
福利及休假：试用期内开始为员工办理五险一金+定期体检+国家法定假日+一年12天带薪年假（入职即可享受）
交通及食宿：工作餐，为外地或倒班员工提供宿舍
其它：定期组织丰富多彩的员工活动