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The Position

l Obey the requirement against global GMP standards and China GMP requirement to improve the compliance level.

Ø By learning of current GMP requirement of Roche Chinese GMP regulatory realize the requirement of cGMP and implemented in daily routine work.

Ø By maintaining the documentation to ensure quality system operations in QC meets the regulatory.

Ø Strictly adhere to the requirements of good document procedure GDP and data integrity DI. Ensure documentation and data compliance with ALCOA principles.
ALCOA

Ø Support regulatory inspections and headquarters audits

l Obey the requirement against global standards government regulations and SHE& QC department requirement

Ø By learning of current SHE requirements from Roche Headquarters government regulations and SHE Department and ensure their implementation in local management processes.

Ø Ensure QCs SHE operation system complies with headquarters government regulations and SHE department requirements by revising SHE documents.

Ø Act as the Single Point of Contact (SPOC) between QC and SHE Department responsible for communication dissemination execution and coordination of all SHE-related matters.

Ø Support and coordinate SHE-related inspections and audits ensuring QC meets all SHE inspection and audit requirements.

Ø Responsible for maintaining and continuously improving the SHE training system to ensure compliance with SHE requirements from headquarters government regulations and SHE Department.

Ø Responsible for the identification assessment and action of QC position-related risks ensuring end-to-end SHE risks are clear and control measures are in place.

Ø Responsible for coordinating SHE periodic management tasks including but not limited to emergency supplies/first aid kit inspections fire/leak drills SHE Gemba occupational health examinations and license renewals.

Ø Responsible for managing QC and team SHE boards tracking SHE-related indicators promptly communicating any SHE risks or incidents that may impact SHE metrics and effectively developing countermeasures.

Ø Responsible for monitoring and reporting any violations of SHE requirements in the laboratory.

l Ensure that the following works are effectively executed to support LS and QC related business

Ø Lab reagents/consumables related including but not limited to

responsible for maintaining and executing end-to-end management processes for reagents/consumables including ordering/request receipt storage distribution inventory and disposal.

Familiar with reagent/consumable management systems and proficient in their use to ensure accurate and efficient support for reagent/consumable management.

Responsible for the management and process maintenance of reagents with special SHE requirements including controlled chemicals explosive precursors and flammable reagents covering special procurement receipt storage and disposal processes.

Ensure laboratory reagent/consumable inventory meets business needs while minimizing waste.

Ø GMP document management related including but not limited to:

Responsible for maintaining and executing the end-to-end management process for logs and records including printing binding numbering utilization usage review return archiving and destruction.

Responsible for the archiving management of laboratory documents.

Ø Laboratory budget and procurement related including but not limited to:

Responsible for the end-to-end management process of laboratory procurement and orders including communicating needs supplier communication for quotations submission of purchase requests placing orders and receipt of goods.

Familiar with procurement systems and proficient in their use to ensure accurate and efficient completion of procurement management tasks.

Monitor laboratory spending and budget promptly communicate any budget overrun risks or incidents and ensure laboratory expenses align with the annual budget.

Ø Local instrument/equipment aspect including but not limit to

Management of the lifecycle process for instrument/equipment and execution of related business operations including verification/validation of instrument/equipment periodic review backup/archive/recovery internal and external calibration and testing decommissioning maintenance and repair contracts and orders etc.

Ø Communication and cooperation with other relevant departments including but not limited to

Collaborate with Procurement about the reagent/consumable instrument/equipment and maintenance/repair services business.

Collaborate with the SHE on the effective implementation of SHE requirement in QC

Collaborate with the Engineering on the QC facility fitness management

Collaborate with other internal/external department to support other business of Roche.

l Project Management & Continuous Improvement

Ø Support QC project management and objective management e.g. Project management capability establish and refresh project portfolio management and follow-up.

Ø Understand the Lean Lab management concept and LPS tools to apply relevant concepts to continuously improve in routine work.

Ø Continuous improve the lifecycle management strategy of equipment and system.

l Laboratory Data Integrity Assurance.

Ø Understand lab DI with Roche standards and implement it in routine work and promote DI requirements.

Ø Ensure QC E2E data integrity based on risk process and data lifecycle.

l Complete the other tasks assigned by leader.

Qualification and Experience

Education/Qualifications
Bachelor of Science Degree or above
Pharmacy Chemistry Biochemistry and equivalent
At least 2 years experience in analytical/ technical registration area /Lab Operation& management of
pharmaceutical industry
GMP implementation experience mindset and lab operation experience
Ownership Capability Goal & Task based working approach.
Careful mindset and strong logical thinking
Having good Influence Without Authority
Language skills English & Chinese

Who we are

A healthier future drives us to innovate. Together more than 100000 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.

Lets build a healthier future together.