Shift Operational Quality Technician

GlaxoSmithKline; Singapore; On-site; SGD 50,000 - 70,000; Full time

Job summary

A leading global biopharma company in Singapore is seeking a Quality Assurance professional to ensure compliance with cGMP standards and quality oversight. The ideal candidate will have a diploma in chemical or bioengineering and a minimum of 1 year of experience in the pharmaceutical industry. Responsibilities include reviewing documents, coordinating audits, and providing quality oversight in manufacturing processes. This role requires strong interpersonal and communication skills, alongside a commitment to delivering high-quality products.

Qualifications

• Minimum 1 year of experience in the manufacturing industry.
• Experience in quality and manufacturing processes.
• Experience in the pharmaceutical industry or healthcare sector.

Responsibilities

• Assess, review, and approve all cGMP related documentation.
• Coordinate, review and approve Periodic Reviews of products.
• Conduct site audit inspection preparation and participate in audits.

Skills

Quality Assurance

Interpersonal Skills

Communication Skills

Investigative Skills

Project Management

Education

Diploma in Chemical Engineering or Bioengineering

Job description

Responsibilities

• Assess, review and approve all cGMP related documentation
• Review batch and quality documentations to assess whether the product is fit for purpose prior to making usage decision
• Assess, review and approve changes that may have an impact on product quality, validation and/or cGMP compliance to ensure timely product release to customers. Upon implementation of changes, review and ensure proper closure of changes.
• Inspect and release process equipment/plant after turnaround
• Co‑ordinate, review and approve Periodic Reviews of products, systems and processes
• Conduct and support site audit inspection preparation and participate as an audit team member in audits, including internal and external audits
• Draft, review, update and be subject matter expert for appropriate procedures and listing relating to cGMP, site supplier management, and operational quality and ensure they are in full compliance with cGMP and GSK requirements
• Support shift operations which include production, engineering, laboratory etc. to provide the necessary quality oversight in terms of activities such as change control, deviation investigation eg. Initial impact and remedial action assessment
• Provide quality oversight of shift operations, laboratory and engineering team in all aspects of GMP, not limiting to regular walk downs to production facilities including supporting areas with the necessary coaching of the shift staff. These areas include but not exclusive to production buildings, laboratories, engineering buildings and storage facilities

Knowledge, Skills & Experience

Professional

• Diploma in chemical engineering or bioengineering
• Min 1 years of experience in manufacturing industry
• Experience in quality and manufacturing processes
• Experience in pharmaceutical industry or healthcare sector
• Open to candidates who are keen in rotating 12 hour – shift

Technical

• Basic knowledge of GMP
• Basic knowledge of quality and manufacturing processes
• Good knowledge of corporate management systems
• Good audit skills
• Knowledge of equipment operations

Business

• Good interpersonal skills
• Good oral and written communication skills
• Good investigating skills
• Good project management skills

To learn more about Singapore GSK and our people, please click on this link: https://www.linkedin.com/company/glaxosmithkline/life/gsksingapore

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.