At Roche you can show up as yourself embraced for the unique qualities you bring. Our culture encourages personal expression open dialogue and genuine connections where you are valued accepted and respected for who you are allowing you to thrive both personally and professionally. This is how we aim to prevent stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche where every voice matters.

The Position

Principle Roles & Responsibilities / Accountabilities (Major functions of the position)

1 Quality Oversight
Collaborate with key stakeholders including manufacturing operations supplier quality quality systems and Planning; provide Quality oversight in Drug Products life cycle and the E2E manufacturing process.

As per the business arrangement the scope of quality oversight should cover the quality activities in all related areas including QC laboratory production plants site PUW PW Environmental Monitoring (EM) and Clean Utility Monitoring programs etc.

Manage and oversee frontline QA activities in plants.

Manage of sampling process for local manufactured products

Perform oversight of Specification process and product monitoring for local manufactured products

Perform oversight of stability program for local manufactured products

Connection with Global Quality take role as quality role across the local manufactured product life-cycle management (Local Quality Role)

Execution of frontline QA activities in plants

Acknowledge the live status in production area according to the DPS and follow up with actual excursions against the DPS identify the potential risks and take preventive action.

Join Tier meeting in production or other Tier meetings
Perform batch record review
Enabling real-time problem solving with production team

2 Implement local manufactured product-related batch release process

Ensure on-time batch disposition per the requirement of Roche Timeline.

Ensure products are not sold or supplied before a QP/AP has released each production batch is produced and controlled in accordance with the requirements of the Marketing Authorization and other regulations relevant

Perform the interaction with EU QP regarding exported batches.

3 Execution of API/direct materials management

Ensure on-time material batch disposition per Roche requirement

Implement oversight of material quality including Specifications Artwork SAP/MES master data Change Deviation/CAPA new material qualification quality management etc.

Support local supplier quality management including audit Quality Agreement etc.

4 Coordination and handling for quality related issue

Implement the management of Event&CAPABe familiar with RCA tools and can independently facilitate related departments to conduct discrepancy investigation ensure the investigation completed within specified due date and supporting products release.

Collaborate with SMEs and Lead investigators to develop investigation strategies
Provide leadership for Local Quality Review Board and participate in Quality Council when needed.
Monitor investigation progress and ensure effective corrective and preventive actions are initiated and executed on time and keep continuous improvement

Handle customer complaint

Perform customer complaint investigation and ensure effective corrective and preventive actions are initiated and executed on time
Lead the investigation of local manufacturing products related complaints.

5 Quality system oversight

Execute QA process/documentation maintenance in a continuously compliant state and a continual state of readiness for regulatory agency inspections

Manage material quality management related to solid products.

Execute the business process management (BPM) of event and CAPA.

Be in charge of Deviation periodic review to seek continuous improvement opportunities

6 Other quality related activities

Support to draft and review the local product APQR.

Involve and support the inspection by HA and Roche Global inspection.

Involve quality related projects.

7 Complete other tasks assigned by senior leaders

Qualification and Experience
Education/Qualifications

Bachelor Degree (4 years education of Pharmacy Pharmaceutical bioengineering Chemistry or equivalent education level)

Graduate or higher-level Degree is preferred

Job Required Competencies

Experience (may vary depending on site size/scope)

5 or more years work experience in the pharmaceutical or related industry
3 or more years experience in a commercially licensed GMP facility

Knowledge/Skills/Competencies

Professional knowledge of Quality System and QA principles practices and standards for the pharmaceutical industry
Rich knowledge of cGMP relevant to the pharmaceutical industry
Knowledge of pharmaceutical biotechnology or medical device related product operations including local and international quality regulations.
Project management skills
Demonstrate good 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 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.