Overview:
This role will oversee and support daily laboratory operations in a pharmaceutical manufacturing environment. Candidates need to have a strong background in laboratory systems, equipment qualification, and compliance with GxP and GMP regulations. The ideal candidate will have hands-on experience with laboratory processes, instrumentation, and regulatory requirements specific to the pharmaceutical industry.
As a Laboratory Operations Specialist, you will ensure the smooth operation of laboratory systems, perform equipment qualification and maintenance, and support the implementation of laboratory improvements that enhance compliance and efficiency.
Key Responsibilities:
Laboratory Operations Management:
Oversee the day-to-day operations of the laboratory to ensure compliance, efficiency, and reliability.
Collaborate with laboratory staff to maintain smooth workflows and resolve operational challenges.
Provide technical support and troubleshooting assistance for IT systems, including hardware, software, and network infrastructure.
Equipment Qualification and Maintenance:
Perform and document laboratory equipment qualification (IQ, OQ, PQ) in compliance with GxP and GMP standards.
Schedule and conduct routine calibration, maintenance, and repairs for laboratory instruments and equipment.
Troubleshoot equipment issues and coordinate with vendors for advanced technical support as needed.
Compliance and Documentation:
Ensure laboratory operations and equipment are compliant with regulatory standards, including GxP, GMP, and other pharmaceutical guidelines.
Maintain accurate and up-to-date documentation for all equipment qualifications, maintenance, and operational activities.
Support audits and inspections by preparing required documentation and addressing compliance queries.
Process Improvement:
Identify and implement improvements to laboratory operations, workflows, and systems.
Assist in the integration of new laboratory technologies and methodologies to enhance efficiency and compliance.
Training and Support:
Train laboratory staff on equipment usage, qualification procedures, and operational best practices.
Provide technical support and guidance to ensure laboratory operations meet high standards of quality and compliance.
Regulatory Support:
Collaborate with quality assurance teams to align laboratory operations with regulatory requirements.
Participate in the development and review of Standard Operating Procedures (SOPs) related to laboratory activities.
Requirements:
Bachelor’s degree in Life Sciences, Chemistry, Biochemistry, or a related field.
Proven experience in laboratory operations within the pharmaceutical manufacturing industry.
Hands-on experience with laboratory equipment qualification (IQ, OQ, PQ) and maintenance.
Strong understanding of GxP, GMP, and other pharmaceutical regulatory requirements.
Proficiency in laboratory instruments and systems, including troubleshooting and maintenance.
Excellent organizational and documentation skills, with strong attention to detail.
Ability to manage multiple priorities in a dynamic, fast-paced environment.
Strong interpersonal and communication skills to collaborate effectively with laboratory staff, vendors, and regulatory bodies.
Contract Period: 12 months, subject to renewal based on performance.
Nusantara Prime Consulting Pte. Ltd (NPC)
is a Singapore based private limited company that focuses on technical consulting solutions led by a team of industry practitioners.
Our Specialist Services include Pharmaceutical focus on Process/Project Engineering and Design, Project Management, Technology Transfer, Regulatory affairs, Commissioning, Qualification, Validation, Quality Assurance & Control and Waste Water processing consultation with aim of ZLD (Zero Liquid Discharge) for a circular economy to clients in the Biopharmaceuticals, Life Sciences and Food and Beverage (F&B) industry in the ASEAN region.
Our Mission
With a holistic thought process, we are dedicated to partnering with our clients on end-to-end solution support delivering life-saving therapeutic drugs to the patients.
Our Vision
To be the most successful and ground-breaking consulting agency; providing best-in-class products and services to support our customers in producing quality healthcare timely and economically.