Analytical Systems Lead - Lab Equipment & Validation

Biopharma Careers; Singapore; On-site; SGD 70,000 - 120,000; Full time

Job summary

GSK in Singapore seeks a professional to ensure analytical equipment and computer systems in quality laboratories are installed, validated, calibrated and maintained in line with quality standards.

You will lead investigations, manage CAPA, validate systems, support change control, and ensure regulatory compliance; training staff and maintaining procedures.

Excellent knowledge of GxP, ATS/ICH, and pharmacopoeia; strong collaboration and people management skills are essential.

Qualifications

• Science degree holder with experience in the field of Chemical, Pharma or Manufacturing industry.
• Good knowledge of GxP and laboratory equipment/ validation.
• Good knowledge of quality, laboratory techniques and laboratory compliance.
• Good knowledge of regulatory expectations /ATS/ICH requirements.
• Good knowledge of analytical equipment capabilities and operational needs.

Responsibilities

• Ensure analytical equipment is maintained and calibrated accurately and timely in accordance with site procedures, ATS and regulatory requirements.
• Lead and/or participate in investigations arising from laboratory equipment/computer systems events and propose effective CAPA to minimize recurrence.
• Perform periodic validation review of systems/laboratory equipment to maintain validation status and re-validate as required.
• Lead or participate in laboratory equipment validation per site procedures and regulatory requirements, including writing/reviewing validation documentation.
• Maintain and support computer systems and laboratory equipment according to change control and access control procedures.
• Perform impact assessments on changes to ensure all affected areas and documentation are updated promptly.
• Revise and maintain laboratory procedures to ensure regulatory, QMS, ATS and pharmacopoeia compliance.
• Ensure a safe working environment in the laboratory and perform 6S inspections.
• Conduct effective training for laboratory staff on computer systems/equipment and relevant procedures.
• Ensure timely and accurate Pharmacopoeia & ATS reviews.

Skills

Communication skills

Teamwork

People management

Interpersonal skills

Investigating skills

Regulatory/compliance mindset

Education

Science degree or diploma in Chemical/Pharma/Manufacturing

Job description

GSK in Singapore seeks a professional to ensure analytical equipment and computer systems in quality laboratories are installed, validated, calibrated and maintained in line with quality standards.

You will lead investigations, manage CAPA, validate systems, support change control, and ensure regulatory compliance; training staff and maintaining procedures.

Excellent knowledge of GxP, ATS/ICH, and pharmacopoeia; strong collaboration and people management skills are essential.