Senior SpecialistExecutive, QA(IMP)

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

1. Principle Roles & Responsibilities / Accountabilities

1.1 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 packaging process.

Participate frontline QA activities in plants.

Manage of sampling process for local packaged products

Perform oversight of stability program for local packaged products

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 escalate timely.

Join Tier meeting in production or other Tier meetings

Perform batch record review able to find the problem in time and try to problem solving

Enabling real-time problem solving with production team

1.2 Implement local packaging product-related batch release process

Ensure on-time batch documentation review 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

1.3 Execution of API/direct materials management

Ensure on-time material batch disposition per Rocherequirement

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

1.4 Coordination and handling for quality related issue

Support the Event&CAPABe able to utilize RCA tools and can 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

Participate Local CAPA Review Board and participate in Quality Council when needed

Support monitor investigation progress and ensure effective corrective and preventive actions are initiated and executed on time and keep continuous improvement

Handle Customer complaint:

Coordinate customer complaint investigation and ensure effective corrective and preventive actions are initiated and executed on time

Handle customer inquiry

1.5 Quality system oversight

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

Support product recall & mock recall

Support manage material quality management in site

Manage repackaging of finished products and labeling management for donation products.

1.6 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.

Document management

1.7 Complete other tasks assigned by senior leaders

Key Interfaces

Manufacturing Engineering Local MSAT Planning Warehouse Safety Medical and Regulatory affairs

Other Quality Functions

PQS document owners/authors

Cross-site and global BPms for Customer complaint and issue management

Global Functions: Regulatory (PDR/PTR) PT Development QPLs TPLs and GxP Supplier Management.

2. 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)

0-2 years work experience in the pharmaceutical or related industry more than 2 years work experience is preferred.

Knowledge/Skills/Competencies

Good accountability of GMP understanding and implementing.

Good accountability of regulatory understanding.

Excellent case driving ability.

Well communication skill and good accountability of problem solving.

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.

Roche is an Equal Opportunity Employer.