深圳招聘

Job Purpose :
The purpose of this role is to implement Supplier Quality strategies to ensure that materials are received by sites that meet GSK requirements and to complement business initiatives currently being or planned to be implemented within GSK Biologicals.

Key Responsibilities:
1. Strategy
? Provide QA input into procurement sourcing group strategies for defined category teams.
?To contribute to sourcing strategy reviews through provision of regulatory and quality compliance data and information
? To evaluate proposed alternative or new suppliers for compliance with the appropriate standards

?Coordinate quality aspects of source changes with GSK sites and, as necessary, contract manufacturers, using those suppliers and materials. Ensure that changes are adequately validated to meet regulatory and GSK requirements. This includes generation of required regulatory documentation.

2. Supplier assessment and approval
?Perform assessments/audits of tier 1 and 2 suppliers within role scope. Agree corrective and preventive action plans with suppliers and manage to completion.
? To manage audit activities such as scheduling, reporting and CAPA management within company systems
? Make recommendations about the continued use of suppliers with marginal compliance based on risk assessment.
?Work with the business to facilitate acceptance of materials and components on certificate of analysis to undertake the necessary activities to maintain a compliant status in respect of these activities.
?To ensure that when new sources are introduced to a site the corporate systems such as audit schedules and databases are suitably updated.
?To undertake QA activities on site in relation to generating and maintaining an approved supplier / manufacturers list

3. Risk management
?Perform investigations into significant quality incidents arising at suppliers and ensure root cause of the problem is identified and appropriate corrective and preventative actions are implemented.
?Communicate results of investigations and/or identified risks to ensure stakeholders understand the technical, regulatory and quality risks.
? Identify any learning from incidents which may be beneficial to GSK sites and to relevant suppliers.
?Identify risks relating to suppliers that may impact GSK and assist in developing strategies for reducing the risks.
4. Supplier quality management and improvement
?Use defined tools, techniques and processes to improve quality and compliance of the supply base, e.g. running quality review meetings, obtaining metrics, trending etc.
?Provide site requirements for inclusion in Quality Agreements and where required negotiate these with suppliers on behalf of other GSK user sites.
?Participate in / organize Quality Improvement and Supplier Quality Review Meetings for designated suppliers (meeting with Site QA Managers and Site Directors)
?Manage process and analytical changes with designated suppliers, ensuring appropriate review with technical and user sites. Ensuring any required validation and regulatory work is completed to required standard. Act as site liaison for supplier aspects of change control and escalate issues and delays as required.
? Review proposed material specifications and assess the capability of the supplier to meet the specification.
?Identify areas for improvement across the category and ensure these are incorporated into companies' quality improvement plans.
5. Regulatory inspections
? Support GSK sites undergoing regulatory inspections, as required.
6. Internal supplier quality processes
?Maintain an awareness of supplier's quality performance and material / component defect levels. Provide such information to other audit teams as part of assessment preparation when required.
? Participate in the development of internal Supplier Quality processes when requested.
? Contribute to reporting and escalation of key issues as required.
? Support the making of usage decisions by site OQ for incoming materials / components.
7. Interfaces
?A member of Procurement Category Team - providing QA input to sourcing decisions and supplier management strategies. Providing performance feedback and developing regulatory requirements which may impact business decisions / activity.
?Routinely interfaces with Site QA Directors and Procurement Category Directors and their teams - a two way communication regarding supplier performance and impact on materials, components and services delivered to the site.
?Participate at Site Quality Council (when appropriate) - to ensure supplier related matters are tabled and appropriately managed through risk management and other appropriate escalation processes
?Links with Regulatory, Technical, R&D and Supply and Logistics functions - to ensure effective communication of issues likely to impact other functions and issues which may require joint resolution.
?Keeps up to date with changes in the regulatory and external environment through established networks - to ensure that any issues likely to impact the supply base are well understood and communicated in order to avoid disruption to supply.

Specialised Knowledge:
Breadth & depth across disciplines or functions; expertise in field required
Mandatory
1. A Science degree or experience in pharmaceutical manufacturing and quality operations.
2.Knowledge of regulatory, GMP and GSK quality requirements and ability to explain these and relate to Biologicals/GMS and supplier operations and apply good business judgment in doing so.
3. Extensive knowledge of technologies used within the material / component supply base.
4.Proficiency and experience in planning and executing audits to identify and reduce significant risks / non-compliances.
5. Awareness and understanding of business environment and ability to build networks with third party suppliers
6.Good influencing and negotiating skills to ensure implementation of appropriate standards, specifications and agreements.
7.Good verbal and written communications skills to ensure effective relay of issues, risks and opportunities so that these are well understood by all parties and that effective actions are put in place.

Preferred
1. Trained in OE tools and techniques to green belt standard.
2. Experience in influencing improvement activity (especially in quality culture and GMP compliance).
3. In depth experience in pharmaceutical manufacturing and quality operations.
4. Demonstrated ability to function effectively across multiple cultures and geographic boundaries.
5. Project Management skills.
6.Ability to function effectively, manage workload with multiple projects and conflicting priorities, often to tight deadlines and achieve results within a matrix management structure.
7. Overview of regulatory documentation requirements for designated area of business

葛兰素史克生物制品(深圳)有限公司(GlaxoSmitKline Biologicals (Shenzhen) Co., Ltd.)由世界第二大制药公司葛兰素史克投资建成， 是一家致力于流感疫苗、大流感疫苗生产与销售的外资公司。 公司位于深圳市光明新区，占地面积6万平方米，注册资本7833万美元。公司流感疫苗项目于2010年3月获评深圳市重大项目，并于2010年5月被认定为深圳市高新技术项目。预计投产后，年产能可达到1500万人份流感疫苗或超过1亿人份的大流感疫苗。我们的愿景是：成为最具吸引力最值得信赖的雇主，生产高价值疫苗实现在中国的持续增长。欢迎您与我们公司一同成长。