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

Leadership & People Management

• Build and retain an inclusive workforce and foster an environment where diversity of thought and perspective are valued.

• Maintain an inclusive team that values diversity of thought.

• Maintain strong partnerships with leaders to ensure alignment on strategic projects and daily operations.

• Take the responsibility for department daily SHE management implement site SHE procedure and program and achieve site corporate /site SHE KPI. Promote SHE culture and improve employee safety behavior.

• Manage performance and development team members to achieve organizational goals and employee personal and professional growth.

• Support manager to build a strong pipeline of talent and robust succession plans for key positions.

• Maintain a culture of continuous improvement and model lean leadership principles.

• Maintain a culture of transparent high performance empowerment and innovation culture.

Technical

Engineering Project Support and Operation Readiness:

• Participate in new facility design and construction including but not limited to process design equipment selection URS review FAT SAT IOPQ APS etc. to contribute to project delivery.

• As a key role support to establish an effective operation system in alignment with the Roches standards including manufacturing system CCS strategy people training and qualification system.

• Lead to establish the procedures related to aseptic techniques good aseptic practices on the shop floor and other relevant processes for aseptic production execution.

• Participate in CCS strategy implementation in operation to ensure a sustaining sterility assurance program setting up.

• Support the filling manager to establish the site aseptic training program and implement it ensure only qualified people perform GMP lots manufacturing.

• Ensure teams competencies in performing the following tasks: e.g. vial washing depyrogenating filling and stoppering crimping.

• Participate in tech transfer collaboration with other functions to ensure the success of new product manufacturing.

• Perform other duties as assigned.

Routine Operation:

• Ensure routine operation compliance with regulations maintain sterile conditions and achieve high-quality production standards.

• Ensure total readiness of manufacturing suites including housekeeping machine materials documents and other resources to ensure product delivery in time and within budget.

• Arrange the filling shifts in routine production participate in operation as an aseptic SME and perform daily review of production batch record deviation according to schedule.

• Lead annual aseptic operators qualification provide on-the-job training to support formalized technical and GMP training.

• Oversee the daily operation monitoring and maintenance of filling equipment to ensure compliance with aseptic requirements.

• Supervise aseptic operations during production and intervene promptly in case of abnormalities.

• Participate in the response of regulator audit and global quality audit as SME during regulatory inspections and audits.

• Raise deviation and involve the root cause investigation including appropriate escalation where needed to ensure closure of deviation within the set timeline.

• Raise change control and provide assessment.

• Execute regular validation activities such as APS.

• Participate in Operational Excellence and Continuous Improvement initiatives.

• Related IT system operations such as SAP MES Veeva Cornerstone.

• Perform other duties as assigned.

Qualification and Experience

Education/Qualifications

• Colleges Degree (Pharmaceutical / Biological is preferred) and above.

Job Required Competencies

• 10 or more years operation experience in the injection pharmaceutical industry MNC Bio-pharma preferred.
• 3 or more years people management experience.
• Experienced in strategic projects of Aseptic Filling facility including design commissioning & qualification Isolator filling line is preferred.
• Strong knowledge of cGMP and regulations relevant to the pharmaceutical industry especially in the biological industry.
• Fluent communications skills in English are preferred and the ability to effectively communicate collaborate and foster positive interactions with team members and stakeholders.

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.