天津招聘

Job Purpose 岗位目的:

1. Ensure the quality assurance of responsible product line, check and control the process according to GMP.

2. Coordinator for investigation of abnormal issues.;

3. Work with other department to improve on-line management to mitigate potential quality risk.

4. Ensure all system and process are validated according to GSK group and regulatory policy

1. Ensure GSKT validation activities are carried out in a manner that is compliant with EU, GQP/GQGs, local regulations, SOPs and Site Validation Master Plan.

Key Responsibilities主要岗位职责:

1. Deal with Deviation. Support investigation of quality impact abnormal issue.
2. Deal with reprocess/rework/repack and return of product.
3. Deal with trial process.
4. Conduct on-line GEMBA to ensure actual practice comply with SOP, regulation and other approved procedure.
5. Review entire batch records and monitoring system record for product release in order to ensure product quality meet standards.
6. Conduct batch release as QP or QP delegation
7. Monitor in-process control of products’ validity which conducted by VS including manufacturing in process control, packaging process control and packaging quality check.
8. Maintain SOP/WI/Form related to OQA department, make sure SOP requirement comply with GMP, regulatory and QMS. Ensure actual practice comply with SOP requirement and optimize procedure during routine work.
9. SAP system: ensure appropriate batch statues control of finished product and batches under investigation.
10. Training and corporate with the operator and other quality related department. Support cross function activities (eg, validation activities, quality improvement project…).
11. Conduct CAPA effectiveness check if necessary.
12. Perform regular GMP inspection (L1/L2) as per plan.
13. Coordinate and prepare product annual product review.
14. Monitor in-process control for product, review updated batch record.
15. As quality representative of SAP, SPC, e-coding, fingerprint system.
16. Prepare report Quality KPI from OQA
17. SPC system: print and review the SPC data, coordinate with system maintenance.

SVMP preparation and update, ensure all the validation activities in next 12 months are included in SVMP. Tracking of site validation activities, ensure all the validation activities included in SVMP are implemented in time

1. VMP and VSR preparation and maintenance. Validation template preparation, update and maintenance. Ensure validation author drafts the document with right template, and training them how to use the template.
2. Act the editor to ensure the document attributes comply with the site procedure
3. Assist validation project owners to manage the validation process, track them to complete the validation work with validation lifecycle.
4. Provide OQA related training.
5. Archive OQA documentation. Make sure documents are in good order and state of completion
6. Draft cleaning validation CLA/ECA select the marker product for multiple product line and calculate the cleaning residue limit. Organize and coordinate relevant departments to implement cleaning validation in time.
7. Review documents to ensure right first time and make sure all documents are prepared in accordance with GMP record.
8. Report to Section Manager and provide suggestions for improving OQA system
9. Any other projects as assigned by the Section Manager or Head of Quality.
10. Understand and comply with the applicable local regulations of Quality, EHS and others, GSK standards for QMS, EHSS etc. and company policy. Adherence to standard operating procedures

Specialized Knowledge 专业知识:

ESSENTIAL

• Education degree and speciality

• Bachelor degree or above, major in pharmaceutics.

• 4 years or above, quality related experiences in pharma industry. Be familiar with quality system (eg.: batch release, change control, deviation and investigation process, complaint handling and audit experience) and relative state and regional law, such as GMP, MHRA.

• Have experience on quality system management, risk assessment and investigation handling.

• Commercial awareness of business environment

• Computer and foreign language level

• Fluently use OFFICE software .

• Well English reading and writing skill, which is equivalent to CET-4. Well listening and speaking skill which can support fluency in English communication.

• Good training skill

• Capability requirement

• Good job morality, honest, careful, responsible.

• High quality sensitivity. Can insist on “Do the right thing”.

• Good comprehensively analytical, communication, association, response and innovation ability.

• Good learning skill.

• General leading and organizing ability.

• Leadership and influencing abilities

• Can be fairness and openness in decision making

DESIRED

• Good interpersonal skills.

• Good project management skill

葛兰素史克公司在中国的历史最早可追溯至20世纪初叶。自20世纪80年代以来，在中国政府改革开放政策的感召下，公司在中国积极投资，将最先进的制药技术、最优质的产品、最新型的商业模式、***化的管理理念和市场营销技巧引入了中国。
葛兰素威康和史克必成公司于2000年12月完成全球性合并，2002年，葛兰素史克(中国)投资有限公司全面完成业务整合并正式宣布成立，成为中国目前规模***的跨国制药企业之一。公司业务由处方药、非处方药、疫苗和消费保健品4大部分组成，投资公司和地区总部位于北京，主要业务中心分设在上海、天津和香港。
葛兰素史克是最早在中国成功兴建合资企业的外国制药公司之一。在进入中国的20多年间，葛兰素史克先后成立了5家公司，目前2家为合资企业，总注册资本超过2.3亿美元。目前公司在全国28个主要城市(包括香港)设立了办事机构，在全国拥有近3000名员工，为中国的医药行业培养了一大批高素质的商业管理人员和技术骨干。