苏州招聘

Acting as one of the core team members in QV team, provide frontline participation in the design, development, qualification and validation of GMP related systems, including laboratory areas meeting cGMP requirements from China, US and EU regulations. Where necessary, manage contractor in various qualification and validation activities.

Role and Responsibilities

• Provide Quality oversight (including technical requirements and regulatory expectations) of site qualification and validation efforts.

• Review/generate key qualification/validation lifecycle deliverables and make sure compliance with in effective procedures.

• Ensure all global and site local SOPs are strictly followed.

• Frontline participation and facilitation in risk-based activities (e.g. impact assessment, risk assessment).

• Responsible for qualification/validation program ownership, execution and documentation.

• Maintain and update corresponding validation plan in responsible area(s).

• Maintain and update corresponding inventory list in responsible area(s).

• Collaborate with Project team as well as departments to ensure validation activities are executed compliantly, with efficiency and effectiveness

• Collaborate with departments to ensure risk management, qualification and validation activities are executed efficiently and effectively.

• Responsible for maintenance of qualified/validated state, provide oversight in periodic review.

• Take initiative to support optimization/establishment of qualification/validation relevant SOPs.

• Support in deviation, change control and CAPA management.

• Couching, per pre-established external personnel management procedure.

Qualifications and Education Requirements

                            

• Bachelor and/or advanced degree within Pharmacy, Chemical with at least 8 years practical experience in the Pharmaceutical/biotechnology industry.

• Experience in process validation, cleaning validation, equipment/instrument qualification, computer system qualification.

• Know-how in qualification and validation establishment, deployment and maintenance.

• Expert in qualification & validation project execution and operation, schedule management.

• New plant project experience is required.

• Excellent communication skills, persistence, commitment.

• Fluent oral & written English skill is required.

                

• Background in international big pharma is preferred, either project experience or working experience.

• Experience in IT system related qualification/validation project is preferred.

• Experience in DI related topic is preferred.

和黄中国医药科技有限公司（简称“ 和黄医药 ”或“ Chi-Med ”）（纳斯达克 / 伦交所：HCM）是一家创新型生物医药公司，在过去20年间致力于发现和全球开发治疗癌症和自身免疫性疾病的靶向药物和免疫疗法。目前，和黄医药共有8个抗癌类候选药物正在全球开发中，并在中国本土市场拥有广泛的商业网络。

和黄医药成立于2002年，为在纽约和伦敦两地上市的和黄中国医药科技有限公司（纳斯达克/伦交所： HCM）旗下专注于新药研发业务的子公司, 研发中心坐落在上海浦东张江高科技园区，海外临床开发及注册中心位于美国新泽西，具有完备的研发平台和GMP生产基地。管理团队成员均有在知名跨国医药和生物医药企业工作的经历，参与了多个全球新药研发；公司目前有500余位来自海内外，拥有丰富新药研发经验的科研人员，8大临床在研药物、 30多项临床试验在全球开展。

和黄医药是一家致力于创新药物研发的生物医药公司，专注于发现和开发治疗癌症和自身免疫性疾病的靶向药物和免疫疗法。 自主研发的抗肿瘤新药呋喹替尼已于2018年9月获国家药品监督管理局批准上市，并于2019年11月获纳入国家医保药品目录。公司的其他候选药物，如索凡替尼、沃利替尼等，也已进入后期开发，有望在2020及2021年上市。