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

Roles & Responsibilities

Engineering Project Support and Operation Readiness:

Equipment and System Support:

• Act as the QC equipment representative to contribute to project design construction and qualification. This including equipment selection URS (User Requirement Specification) review FAT (Factory Acceptance Test) SAT (Site Acceptance Test) and IOPQ (Installation Operation and Performance Qualification) to ensure successful project delivery.

• Establish and develop the QC equipment maintenance operation system in alignment with Roche standards. This involves creating a maintenance management system people training and qualification programs and an automation strategy(eg. LIMS Empower SAP) and implementation to support robust operational readiness.

Lab Materials and Sample Management:

• Lead the setup of sample and material management processes for QC operations.

• Ensure all necessary processes documentation (SOPs) and tracking systems are in place for the management of samples and testing materials from day one.

QC Quality System Establishment:

• Collaborate closely with site and project organizations to ensure the new facility meets Roche business goals.

• Participate in technical transfers and work with other functions to ensure the successful manufacturing of new products.

• Draft and/or review SOPs project documents and validation activities to ensure they are in place for the companys launch.

• Oversight OOS/OAL/OOA/OOT processes.

• Support all QC activities during regulatory inspections and audits and participate in the response to regulatory and global quality audits.

• Support manager to develop a competent team through coaching mentoring and training by having in place a skill competencies development and appraisal program to strengthen the technical expertise and capabilities.

Routine Operation:

Safety Management:

• Maintain strict adherence to Roches SHE (Safety Health Environment) standards and all regulatory guidelines.

• Ensure all lab support activities including equipment maintenance and material handling are conducted with the highest safety standards to protect personnel.

• Actively promote a safety-first culture within the team and report any incidents or deviations promptly.

Equipment Lifecycle Management:

• Serve as the system owner accountable for the operation and maintenance of all QC lab equipment.

• Develop and execute preventive and corrective maintenance programs to maximize equipment availability and optimize life-cycle costs.

• Plan and coordinate maintenance activities with various departments ensuring that resources parts and vendors are available on schedule to ensure efficient and uninterrupted plant operation.

• Propose spare parts and manage the maintenance budget for responsible equipment.

• Drive initiatives to improve asset reliability and operational performance to achieve financial objectives and gain cost competitiveness.

System Lifecycle Management:

• Oversee the Computerized System Validation (CSV) lifecycle for all relevant lab systems.

• Ensure all computerized systems are maintained in a validated state throughout their operational life.

• Manage change control processes for system updates and modifications.

• Drive operational excellence through the implementation of digital solutions and continuous improvement initiatives.

• Support the integration of new technologies and digital tools to enhance lab efficiency and data management.

Data Integrity Assurance:

• Be responsible for the quality and accuracy of all data and records generated by lab equipment and maintenance activities.

• Ensure all data is maintained in accordance with cGMP and company standards for data integrity.

Sample and Material Management:

• Manage the end-to-end sample and testing material management process including IPC sample DS and package materials DP release and stability samples EM samples and retention samples.

• Ensure the proper receipt logging storage and traceability of all samples according to established SOPs.

• Oversee the tracking and timely delivery of samples for testing as well as the secure disposal of materials.

• Stabilityretention sample management

QC Compliance Assurance:

• Ensure audit readiness by complying with effective standards regulatory/statutory and cGMP requirements. Participate in the response to regulatory audits and global quality audits.

• Be accountable for the operation and maintenance of relevant equipment with Roches GMP/EHS standards and regulatory guidelines.

Qualification and Experience

Education/Qualifications

• Bachelors Degree (Life Sciences Pharmaceutical Sciences and Analytical Sciences is preferred) and above

• Strong knowledge of QC operation and maintenance with experience in aseptic processes preferred

Leadership Competencies

• Take a genuine interest in people

• Listen carefully tell the truth and explain the why

Job Required Competencies

• 5 or more years of QC experience MNC Bio-pharma preferred

• 3 or more years of people management experience

• In-depth knowledge of quality control procedures and legal standards.

• Strong knowledge of mathematics data analysis and statistical methods.

• Experienced in strategic project of QC design commissioning & qualification

• Experienced in QC new facility startup readiness and operation ramp up including organization people and operation management system.

• Experienced in QC routine operation and QC systems( Empower)

• Advanced knowledge of regulatory requirements in the industry. Experience with compliance inspection by NMPA/FDA/EMA/TGA/PMDA.

• Familiar with the inspection knowledge of disposable materials relevant hands-on experience is preferred.

• Strong knowledge on operation and maintenance of QC operational excellence ( and 6 Sigma).

• Able to think strategically and translate strategies into actionable plans understands and applies agile ways of working

• Fluent communications skills in English and the ability to effectively communicate collaborate and foster positive interactions with team members and stakeholders across the network.

• Empower and trust people to make decisions

• Discover and develop the potential in people

• Strive for excellence and extraordinary results

• Set priorities and simplify work

• Congratulate people for a job well done

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.