QC System Analyst

ORKA CONSULTING PARTNERS PTE. LTD.; Singapore; On-site; SGD 60,000 - 80,000; Full time

Job summary

A consulting firm specializing in Life Sciences is seeking professionals to deliver consulting projects related to laboratory enterprise systems. The ideal candidate will hold a Bachelor’s degree in Life Sciences or Engineering and have at least 2 years of relevant experience in the pharmaceutical or medical device sector. Responsibilities include drafting regulatory deliverables and supporting system integration. Opportunities for professional development and impactful learning are emphasized within the firm.

Benefits

Career development opportunities

Professional environment

Access to mentors and training materials

Qualifications

• Minimum of 2 years in a pharmaceutical or medical device environment.
• Experience in configuring laboratory systems.
• Knowledge of computerised systems regulatory requirements.

Responsibilities

• Deliver consulting projects for laboratory enterprise systems.
• Draft CQV and CSV deliverables.
• Support equipment integration with other systems.

Skills

System configuration

Understanding of regulatory requirements

Technical knowledge of Windows OS

Change, incident and problem management

Education

Bachelor’s degree in Life Sciences or Engineering

Tools

LIMS (Labware), LES (Biovia), ELN, CDS (Empower, OpenLab)

Job description

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.
• Fresh graduates with internship in pharmaceutical or medical device industry and some relevant experience may apply for a Junior role.
• Experience in configuring systems like LIMS (e.g., Labware), LES (e.g., Biovia LES), ELN, CDS (e.g., Empower, OpenLab), etc.
• 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.
• Preferably with technical knowledge of Windows OS, security system and backup system.

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 Intelligent, Resourceful, Loyal 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.