Senior Specialist/Associate Manager, QA Packaging

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.

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 repackaging products and IMP materials life cycle and the E2E process.

• As per the business arrangement, the scope of quality oversight should cover the quality activities in all related areas including warehouse operation and packaging plants.

• Manage and oversee frontline QA activities of repackaging products and IMP products in plants.

• Manage of sampling process for repackaged products

• Perform oversight of Specification, process and product monitoring for repackaging products

• Perform oversight of stability program for repackaging products

• Connection with Global, take role as quality role across the repackaging product life-cycle management.

• Execution of frontline QA activities in plants and warehouse

-- 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 and warehouse or other Tier meetings

-- Real-time problem solving with production and warehouse team

2 Implement repackaging and additional labeling IMP product-related batch release process

• Ensure on-time batch documentation review per the requirement of Roche Timeline and resolve the identified issue independently.

• 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

• Additional labeling IMP batch release.

3 Execution of direct/ IMP materials management

• Ensure on-time direct material batch disposition per Roche requirement

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

• Support local supplier quality management including audit, Quality Agreement etc.

• Clinical trial material shipping documents check and system release

• Temperature excursion evaluation during transportation for local sourced IMPs.

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

4 Coordination and handling for quality related issue

• Implement the management of Event &CAPA:Be 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

--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 repackaging products and IMP related complaints.

• Responsible for escalation of significant quality issues following the criteria as defined in the current governing documents.

5 Other quality related activities

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

• Support to draft and review the local product APQR.

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

• Involve quality related projects, e.g., product and process transfers from or to other locations and partners

• Document management

6 Complete other tasks assigned by senior leader

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

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.

Roche is an Equal Opportunity Employer.