Specialist (Laboratory System Qualification - Lab Support)

The position of Specialist in Quality Laboratory Support will be responsible for ensuring and maintaining high standards of quality and compliance within our organization.

In this role, you will be responsible for all or subset of the key responsibilities below:

• Perform/review laboratory system lifecycle management, including risk-based approach system qualification/retirement, commissioning/decommissioning, system administration, periodic temperature mapping, and system periodic reviews, in accordance with approved procedures and standard lead time.
• Raise purchase requests and perform orders confirmation, asset settlement and accrual for laboratory system lifecycle management (LCM) and Capital Expenditure (CAPEX) within stipulated timeline.
• Execute section and Quality improvement initiatives and other special projects, ensuring alignment with business goals and timelines.
• Assume role of Subject-Matter-Expert of laboratory system lifecycle, collaborates closely with cross-functional teams and above-site functions. This includes initiating alignments proactively, sharing expertise, and providing input to ensure alignment and consistency across the organization.
• Perform/review system administration related documents such as LabX method building, System Inventory Listing, eshopfloor logs, eVal, etc.
• Perform assessments of compendial updates and implement changes to Standard Operating Procedures, Work Instructions and other GMP documents.
• Author Quality Notifications, support root cause analysis and ensure effective implementation of related actions within the agreed timeframe.
• Conduct troubleshooting of laboratory system lifecycle, identifying and resolving any issues that may impact the business/work efficiency and compliance.
• Identify opportunities and propose solutions to improve efficiency and compliance in processes, standards, and best practices within the team.
• Provide skills training to other team members, ensuring they have the necessary knowledge and competencies to perform their duties effectively.
• Support and respond to audit requirements and findings.
• Any other duties as assigned by reporting manager.

Qualifications and Skills:

• Degree in a relevant scientific or technical discipline (e.g., Chemistry, Biochemistry, Pharmaceutical Science, Engineering, IT with GxP experience).
• Minimum 3 years of applied professional work experience in Equipment Qualification and Computerized Systems Validation in a GMP-regulated environment.
• Preferably work experience specifically in GMP regulated QC Laboratory or Lab Systems Support (e.g., LabX, Empower) and working knowledge of laboratory system lifecycle management, calibration & maintenance, and Data Integrity.
• Leadership skills and ability to influence/collaborate with stakeholders at various levels.
• Customer focus with strong business acumen and continuous improvement mindset.
• Strategic and critical thinking mindset with a collaborative and problem-solving attitude.
• Strong communication and interpersonal skills.
• Attention to detail and ability to prioritize tasks effectively at appropriate level.
• Ability to work effectively in a team-based environment.