Senior QC Specialist

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

Job summary

GSK Tuas Vaccines in Singapore is seeking a QC Specialist/Senior QC Specialist to support QC activities on new projects. You will represent the Tuas QC unit and collaborate with global QC, Belgium QC and MSAT to ensure method validation, transfer and equipment qualification are completed.

The role leads validation activities, develops master plans, ensures GMP compliance, and drives knowledge transfer to routine testing while coordinating with stakeholders and managing budgets.

Qualifications

• Bachelor’s degree in chemistry, biochemistry, microbiology, life sciences or a related discipline.
• Minimum 4 to 6 years’ experience in a QC or analytical laboratory, preferably in pharmaceutical or life sciences settings.
• Practical knowledge of GMP principles and laboratory quality systems.
• Hands-on experience with analytical methods and laboratory investigations.
• Experience coordinating method validation, verification or transfer activities.
• Good written and verbal communication skills in English.

Responsibilities

• Leads method validation, development, verification, transfer and new equipment/technology introduction.
• Provides expertise and consultation to projects team on technical QC matters to ensure compliance to applicable regulations.
• Ensures timely implementation of the projects with full compliance to corporate, regulatory and external agency regulations if applicable.
• Keeps up-to-date on regulations/development of biopharmaceutical QC method/technology to maximize digitalization, automation and robotics.
• Works closely with global/local QC stakeholders to develop analytical transfer plan and validation master plan, cost management and training plan.
• Collaborates with global QC on test method innovation to support facility design/modification for QC operations.
• Writes/reviews change controls, events/deviations, CAPAs and GMP documents.
• Ensures spendings are within project target budget.
• Perform testing when required to adhere to test release and project plan.
• Respects safety and security policies, laboratory policies and SEHSS on site.

Skills

Data Integrity

Detail-Oriented

Digital Fluency

GxP Regulations

Lean Management

Problem Solving

Quality Assurance (QA)

Quality Control (QC)

Risk Awareness

Testing Operations

Education

Bachelor's degree in chemistry

MSc in a relevant field

Tools

Laboratory equipment qualification

Calibration programs

Computerized systems

Job description

To provide technical support to the projects team for Quality Control (QC) related activities for the new projects introduced in GSK Tuas Vaccines. He/she represents Tuas QC unit and collaborates with global/Belgium QC as well as global Manufacturing Science and Technology (MSAT) in all areas of QC validation and operation. The QC Specialist / Senior QC Specialist ensures that all aspects of QC testing of the new projects, test method validation, analytical equipment qualification, analytical method transfer, laboratory and analytical capacity are successfully completed. For new analytical test methods introduced, the QC Specialist / Senior QC Specialist ensures that the local QC unit participates in the method development and validation. He/ She will also support the local QC unit to be ready to transit into lifecycle management.

Responsibilities

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

Project Management

• Leads method validation, development, verification, transfer and new equipment / technology introduction. Performs testing for project related activities as required.

• Provides expertise and consultation to projects team on technical QC matters to ensure compliance to applicable corporate, regulatory and external agency regulations.

• Ensures timely implementation of the projects with full compliance to corporate, regulatory and external agency regulations if applicable.

• Keeps up-to-date on regulations/ development of biopharmaceutical QC method/ technology to ensure the project maximizes the use of digitalization, automation and robotics.

• Works closely with global/local QC stakeholders to develop and endorse the following: –Analytical transfer plan and Validation master plan, cost management (eg. facility, analytical equipment) and training plan

• Collaborates closely with global QC departments on test method innovation/ evaluation to support the project team in facility design / modification specifically for QC operations.

• Writes/ reviews change controls, events/ deviations, CAPAs and GMP documents (e.g. SOP, protocols, reports).

• Ensures spendings are within project target budget.

• Perform testing when required to adhere to test release and project plan

• Respects all safety and security polices, laboratory policies and practices on site and ensures policies and SEHSS are deployed and respected.

QC Operation

• Anticipate, plan and execute the transition from a project mode to routine mode in terms of QC operations.

• Knowledge management on knowledge retention and effective training to ensure methods/ knowledge are effectively transferred to routine testing team.

Why You?

Basic Qualification

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

• Bachelor’s degree in chemistry, biochemistry, microbiology, life sciences or a related discipline.

• Minimum 4 to 6 years’ experience in a QC or analytical laboratory, preferably in pharmaceutical or life sciences settings.

• Practical knowledge of GMP principles and laboratory quality systems.

• Hands-on experience with analytical methods and laboratory investigations.

• Experience coordinating method validation, verification or transfer activities.

• Good written and verbal communication skills in English.

Preferred Qualification

If you have the following characteristics, it would be a plus

• Advanced degree (MSc) in a relevant scientific discipline.

• Experience with chemistry, biochemistry, environmental monitoring and water system testing.

• Experience with stability testing and stability data review processes.

• Familiarity with laboratory equipment qualification, calibration programs and computerized systems.

• Experience supporting regulatory inspections as a subject matter expert.

• Experience leading or coaching small teams and driving continuous improvement.

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?

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 [e-mail]. Please note this email is for adjustment requests only; for other enquiries please use our standard contact channels.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK’s commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

#Li-GSK