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The Position

Primary Purpose of Job (Job Summary)

Responsible for Quality oversight of  the planning and execution of all qualification and validation activities within PT China, including but not limited to equipment qualification, process validation, cleaning validation, method validation, digital systems validation and technical transfer, to ensure the compliance with company policies and requirements, global standards & procedures, and all relevant GxP regulations.

Responsible for Quality oversight of the roll out of IT and digital systems in GxP areas is compliance with global Quality Requirements and relevant regulation requirements.

Ensure the Data Integrity (DI) requirements are fully embedded into routine GxP activities in PT China and drive the continuous improvement of DI Maturity following the global program.

Principle Roles & Responsibilities / Accountabilities

Quality oversight of the qualification and validation processes

Review and approve site Validation Master Plan (VMP)/project plans and ensure the strategy meets business and regulatory requirements. As needed, review/approve validation protocols, engineering change orders, Standard Operation Procedures (SOP), engineering commissioning and turnover packages.

Ensure the qualification and validation processes execution are in the way of compliance. This applies across the entire lifecycle of the processes and equipment. This includes:

• Plant qualification of production equipment, QC equipment and the entire infrastructure (purified water, HVAC, process gases). 

• Validation of production, cleaning and transportation processes

• Oversight of product and process transfers from or to other locations and partners

By providing an umbrella guidance document to drive a structured approach to all qualification and validation activities.

Review and approve all relevant documentation and ensure documentation supports a compliant state.

Oversight of computerized system validation activities and routine operation

By governance the execution progress of CSV activities to assure the compliance with QMS, site CSV master plan, company operating procedures, and regulatory requirement.

By developing overall local CSV strategy and promoting continuous improvement in the level of understanding of CSV knowledge and practice.

By implementing Data Integrity principle during CSV monitoring and execution.

By participating in CSV activities for all the IT and digital systems used in GxP areasto monitor GxP compliance.

By reviewing or approving CSV plans, reports and other related documents according to GxP regulations and ensuring consistency of documentation.

Oversee GxP IT systems (eg. LIMS, MES, SAP) used for supporting materials/products quality management in site to ensure they are always within a validated status. Ensure all master data or data maintenance are correctly conducted in the system.

Work as super user of IT systems (SAP, MES, etc.) for quality related activities.

Quality Digital System projects relevant

Participate or lead the local rollout or implementation of the global cross-functional project (eg. Aspire), ensure the project can be delivered efficiently and handover to end users smoothly.

Act as the leading role during the project as well as routine business operation, perform problem solving timely and ensure the business operates smoothly.

Data Integrity Management

Accountable for development and sustainment of PT Data Integrity assurance, manage and maintain the procedures for Data Integrity assurance.

Providing guidance and training regarding Data Integrity assurance to relevant PT stakeholders.

As Site Data Integrity Lead, review and provide technical guidance on procedures for data integrity assurance to relevant stakeholders.

As Site Data Integrity Lead, participate in regular global DI meetings, and drive local DI improvement projects actively.

Lead and coordinate local DI maturity assessment

Complete the tasks assigned by senior leaders

Based on business needs, be responsible for the main roles outlined in sections 3.1-3.4, acting in either a lead or support role.

Complete other tasks assigned by senior leaders

Qualification and Experience

Education/Qualifications

Bachelor Degree (Pharmacy, Pharmaceutical, bioengineering, Chemistry or equivalent discipline is preferred)

Leadership Competencies

Be able to coach colleagues with their knowledge/skill.

Be able to participate in large/global cross-functional or cross-chapter squads where it may take a leading role.

Navigates in complex situations by applying a diverse skillset.

Job Required Competencies

Experience (may vary depending on site size/scope)

• 7 or more years’ work experience in the pharmaceutical or related industry

• 3 or more years’ experience in a commercially licensed GMP facility

• Experience on solid and/or aseptic processing is preferred

Knowledge/Skills/Competencies

• Expert with professional knowledge of qualification, validation, digitalization in Pharmaceutical Area

• Expert knowledge of GxP regulation.

• Strong knowledge of pharmaceutical, biotechnology or medical device related product operations including local and international quality regulations.

• Project management skills

• Excellent communication and collaboration skills. As a key liaison to various functions, be responsible for coordinating resources and ensuring all project stakeholders align on quality and timeline objectives.

• Demonstrate excellent verbal and written communication skills in English

• Focus on value and customer

• Learn for the future

Who we are

A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.

Let’s build a healthier future, together.