Instrumentation Qualification Analyst at Adcock Ingram

Job Outputs:

Equipment Calibration and Maintenance:

• Perform scheduled preventative maintenance (PM) and calibration on laboratory equipment as per the qualification protocols and guidelines.
• Update and manage calibration statuses and ensure all analytical instruments meet calibration requirements.
• Troubleshoot out-of-limit calibration results, referring to instrument manuals and liaising with suppliers to resolve issues. 

Instrument Qualification (IQ/OQ/PQ):

• Coordinate and execute the installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) activities for new and existing equipment.
• Review and approve equipment qualification protocols, calibration procedures, and change control documents.
• Ensure all qualification activities are documented, traceable, and stored according to regulatory requirements. 

Documentation and Records Management:

• Maintain and update equipment history records, including calibration certificates, repair logs, and qualification reports.
• Ensure all laboratory equipment has associated SOPs (Standard Operating Procedures) and instrument manuals available for use.
• Initiate and update new SOPs in line with regulatory and operational requirements.

Supplier and Vendor Management:

• Communicate with suppliers for repairs, maintenance, and technical support for laboratory equipment.
• Coordinate with external vendors for specialised calibration and qualification activities.

Training and Compliance:

• Train laboratory personnel on calibration concepts, procedures, and the proper use of laboratory instruments.
• Ensure adherence to GLP, GMP, safety standards, and regulatory guidelines during all instrument-related activities.
• Address GLP and safety audit findings within the stipulated timelines.

Requirements

Educational Requirement:

• Bachelor of Science (BSc) degree with a major in Microbiology, Chemistry, or a related field.
• National Diploma in Microbiology, Medical Technology, Bacteriology, or Chemistry.

Additional Certifications:

• Certification in Good Laboratory Practices (GLP) or Instrument Qualification would be advantageous.
• Training in equipment qualification (IQ/OQ/PQ) is preferred.

Minimum Required Experience:

• Minimum of 3–5 years of hands-on experience in the pharmaceutical industry, with specific exposure to laboratory equipment calibration, maintenance, and qualification.
• Proven experience in IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification) activities for analytical instruments.

Preferred Experience:

• Practical knowledge of cGMP, GLP, and regulatory requirements for pharmaceutical laboratories.
• Experience in handling audits related to equipment qualification and maintenance records.