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.
