SERM Scientific Director

GlaxoSmithKline Pte Ltd; Singapore; On-site; SGD 60,000 - 90,000; Full time

Job summary

GlaxoSmithKline Pte Ltd in Singapore seeks a Laboratory Equipment & Systems Specialist to install, validate, calibrate and maintain analytical equipment and computer systems in quality laboratories. You will ensure procedures align with QMS and regulatory requirements and manage data configurations for lab systems.

The role includes leading investigations, performing validation reviews, and supporting change and access controls while ensuring cGMP and safety compliance.

Qualifications

• Science degree or Diploma with extensive experience in 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

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 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.

Skills

Data Integrity

Detail-Oriented

Digital Fluency

GxP Regulations

Lean Management

Problem Solving

Quality Assurance (QA)

Quality Control (QC)

Risk Awareness

Education

Science degree

Science diploma

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

• 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.

Why You?

Basic Qualification

We are seeking professionals with the following required skills and qualifications to help us achieve our goals.

• 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 AwarenessTesting Operations

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a purpose to unite 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 ••••@gsk.com. Please note this email is for adjustment requests only; for other enquiries please use our standard contact channels.

#Li-GSK