Engineering Project Support and Operation Readiness:

Equipment and System Support:

• Act as the QC equipment SME to contribute to project design construction and qualification. This includes participating in equipment selection URS (User Requirement Specification) review and IOPQ (Installation Operation and Performance Qualification) to ensure successful project delivery.

• Support the establishment and development of the QC operation system in alignment with Roche standards. This involves creating a maintenance management system and an automation strategy(eg. LIMS Empower SAP) and implementation to support robust operational readiness.

• Lead the setup of sample and material management processes for QC operations and ensure all necessary processes documentation (SOPs) and tracking systems are in place for the management of samples and testing materials from day one.

• Lead the setup of sample and material management processes for QC operations and ensure all necessary processes documentation (SOPs) and tracking systems are in place for the management of samples and testing materials from day one.

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

• As the experienced SME proactive drive the continuous improvement in Lab support team by leading the taskforce to identify and implement new technologies to improve the compliance and efficiency in routine QC operations.

Routine Operation:

Safety Management:

• Be the QC SHE SPOC and to maintain strict adherence to Roches SHE (Safety Health Environment) standards and all regulatory guidelines.

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

Equipment and Method Lifecycle Management:

• Be responsible for the operation and maintenance of relevant equipment with Roches QMS standards and regulatory guidelines.

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

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

• 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.

• Support the lifecycle management of analytical methods including implementation transfer and periodic review to ensure compliance with cGMP and Roche standards.

Data Integrity Assurance:

• Ensure the QC data flow generated by lab equipment and maintenance activities are compliance to DI requirements.

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

Sample and Material Management:

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

• Conduct Stabilityretention sample management with compliance to cGMP.

QC Compliance Assurance:

• Ensure audit readiness by complying with effective standards regulatory/statutory and cGMP requirements

• Provide technical support on all lab-related topics during internal and external audits.

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

• Models Integrity

• Focus on value and customer

• Align for success

• Deliver results

• Learn for the future

Job Required Competencies

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

• Sound knowledge of quality control procedures and legal standards.

• Sound knowledge of mathematics data analysis and statistical methods.

• Experience in strategic project of QC design commissioning & qualification

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

• Experience in operation and maintenance of QC operational excellence ( and 6 Sigma).

• Have the potential to think strategically and translate strategies into actionable plans understands and apply 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.