Analytical Support Officer

GlaxoSmithKline; Singapore; On-site; SGD 70,000 - 110,000; Full time

Job summary

GlaxoSmithKline is seeking an Analytical Equipment Validation Specialist in Singapore to ensure installation, validation, calibration and maintenance of analytical equipment and computer systems in quality laboratories in line with QMS standards and regulatory requirements.

The role includes leading investigations, performing validation reviews, updating procedures, and training staff to maintain cGMP compliance and high data integrity across the lab environment.

Qualifications

• Science degree (or Diploma) with extensive >5 years in Chemical, Pharma or Manufacturing industries.
• Strong knowledge of GxP and laboratory equipment validation.
• Experience with regulatory expectations (ATS/ICH) and laboratory compliance.

Responsibilities

• Maintain and calibrate analytical equipment in line with site procedures and regulations.
• Lead and participate in investigations arising from equipment or computer system events; propose CAPA.
• Perform periodic validation reviews and recommend re-validation as needed.
• Lead or support equipment validation activities, including documentation review and approvals.
• Maintain computer systems and lab equipment per change and access controls.
• Assess impacts of changes to equipment/systems and update related documentation promptly.
• Update laboratory procedures to comply with regulatory and QMS requirements.
• Ensure safe lab environment and conduct 6S inspections.
• Provide training to staff on systems/equipment and procedures.
• Ensure timely Pharmacopoeia & ATS reviews.

Skills

Data Integrity

Digital Fluency

GxP Regulations

Quality Assurance

Quality Control

Risk Awareness

Testing Operations

Lean Management

Problem Solving

Detail-Oriented

Education

Science degree/ Diploma with >5 years in Chemical/ Pharma/ Manufacturing

Job description

To ensure the analytical equipment and computer systems in the quality laboratories are installed, validated, calibrated and maintained according to relevant quality standards and procedures. To ensure the equipment and computer systems related procedures are created and updated according to the QMS standards and guidelines and static data configuration for laboratory related systems are managed in a timely manner and meet regulatory requirements. To provide laboratory infrastructural support to ensure that all process raw materials, intermediates and final products are properly analysed and the analytical tests are performed in full compliance with cGMP, regulatory and safety requirements.

Responsibilities

This role will provide YOU the opportunity to lead key activities to progress YOUR career.

These responsibilities include some of the following:

• Ensure that 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 reoccurrence.
• Perform periodic validation review of systems/laboratory equipment in a timely manner to ensure that the validation status is maintained and make recommendations for re-validation as required.
• Lead or participate in laboratory equipment validation in accordance with site procedures and regulatory requirements, inclusive of writing, reviewing and approval of validation related documentations
• Maintain and support computer systems and laboratory equipment according to site change control and access control procedures.
• Perform accurate and thorough impact assessment on laboratory equipment, systems change control to ensure all impacted areas are adequately assessed and impacted documentation are updated in a timely manner.
• Revise, review and maintain laboratory procedures, instructions, methods to ensure compliance with regulatory, QMS, ATS and pharmacopoeia.
• Ensure a safe working environment in the laboratory and perform 6S inspection.
• Conduct effective training for laboratory staff on computer systems/equipment and relevant procedures.
• Ensure timeliness and accuracy of Pharmacopoeia & ATS review.

Basic Qualification

• Science degree holder with experience in the field of Chemical, Pharma or Manufacturing industry or Science diploma holder with extensive >5 Years 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
• Good communication skills
• Good teamwork
• People management skills
• Good interpersonal skills
• Good investigating skills

Skills

• Data Integrity
• Detail-Oriented
• Digital Fluency
• GxP Regulations
• Lean Management
• Problem Solving
• Quality Assurance (QA)
• Quality Control (QC)
• Risk Awareness
• Testing Operations

Why GSK?

Unifying science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a purpose to unify science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale. People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people. We are committed to creating an inclusive workplace and providing equal opportunities for all applicants. We embrace an agile working culture across our roles, so if flexibility is important to you please discuss opportunities with our hiring team. If you need any adjustments to the recruitment process to help you demonstrate your strengths and capabilities, contact [e-mail]. Please note this email is for adjustment requests only; for other enquiries please use our standard contact channels.