Job Summary

Deliver laboratory equipment commissioning and qualification (CQ) and computer system validation (CSV) services to pharmaceutical and medical device clients, driving compliance and operational excellence through strategic implementation and technical leadership.

Responsibilities

• Deliver laboratory equipment Commissioning and Qualification (CQ) services to pharmaceutical and medical device clients.
• Implement laboratory enterprise systems such as LES and LIMS for pharmaceutical and medical device clients.
• Author, review and approve Data Integrity (DI) and Computer System Validation (CSV) documents for quality control (QC) equipment and system.
• Draft and review CQV and CSV documentation including User Requirement Specifications (URS), risk assessments, audit trail assessments, Electronic Records and Electronic Signatures (ERES) assessments, Installation/Operational Qualification (IOQ) protocols, specifications, and Requirements Traceability Matrices (RTM).
• Execute CQ and CSV activities.
• Support integration of laboratory equipment with other systems such as networks, manufacturing systems, and enterprise systems to enable seamless data flow and operational efficiency.
• Manage deviation and non-conformance investigations, Corrective and Preventive Actions (CAPA), and change control processes related to QC equipment and systems.
• Draft, revise, and review Standard Operating Procedures (SOPs), forms, and related operational and maintenance documents to support laboratory quality systems and compliance.

Preferred competencies and qualifications

• Experience in performing QC equipment CQ and / or becoming equipment system owner.
• Experience configuring laboratory systems such as LIMS (e.g., Labware), LES (e.g., Biovia LES), Electronic Laboratory Notebooks (ELN), and Chromatography Data Systems (CDS) (e.g., Empower, OpenLab, Chromeleon) will be an added advantage.
• Experience qualifying laboratory equipment integrated with computerized systems in pharmaceutical or medical device environments.
• Minimum 4 years of experience working in pharmaceutical, medical device, or related regulated environments.
• Bachelor’s degree in Life Sciences, Engineering, or a related field.

Company Overview / Employee Value Proposition

ORKA Consulting Partners (‘ORKA’) was founded as a multi-disciplined business consultancy providing value-added technical and digital transformational services to our customers across various industries. At a time when the world markets and supply chains are evolving fast and increasingly unpredictable, we established ORKA to provide timely and agile support to help our customers navigate a more volatile and complex industry landscape.