QC System Analyst

Key Responsibilities:

• Deliver consulting projects to support implementation of laboratory enterprise system (e.g., LES, LIMS) in the Life Sciences clients.
• Deliver consulting projects to support introduction, upgrade and maintenance of laboratory equipment with computerised system in the Life Sciences clients.
• Draft CQV and CSV deliverables such as URS, risk assessment, audit trail assessment, ERES assessment, IOPQ protocols, specifications and RTM.
• Execute CQ and CSV activities.
• Support equipment integration with other system such as network, manufacturing system and enterprise system.
• Support system configuration and CS activities such as backup and restore, access management, periodic review, etc.
• Draft, revise and review SOPs, forms and related operational and maintenance documents.

Requirements:

• Hold Bachelor’s degree in Life Sciences, Engineering or related field.
• Have worked at least 2 years in pharmaceutical, medical device or related environment.
• Preferably experience in configuring systems like LIMS (e.g., Labware), LES (e.g., Biovia LES), ELN, CDS (e.g., Empower, OpenLab), etc.
• Preferably experience in Windows Upgrade of computerised laboratory equipment.
• Understand computerised system regulatory requirements (e.g., 21 CFR Part 11, Annex 11) and industry best practice (e.g., ISPE GAMP5).
• Preferably with experience qualifying laboratory equipment with computerised system in pharmaceutical / medical device settings.
• Preferably with experience in change, incident and problem management.

Why Join ORKA:

• Work that Matters: Support clients bringing innovative and life saving solutions to the population.
• Career Development: Build a consulting career in a professional consulting company with Life Sciences focus.
• Professional Environment: Work with similar professionals possessing Intelligence, Resourcefulness, Loyalty and Teamwork characteristics.
• Impactful Learning and Mentoring: Develop yourself in an environment that heavily foster learning attitude and benefit from access to training materials, references, mentors and management with wide range of regulated industry experiences.