Senior QA Operations Executive (Materials)

GSK

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profile Job Location:

Singapore - Singapore

profile Monthly Salary: Not Disclosed
Posted on: 2 days ago
Vacancies: 1 Vacancy

Job Summary

You will support and lead quality assurance activities at our Singapore site. You will help maintain and improve our Quality Management System and support manufacturing training documentation and batch release activities. You will work with cross-functional teams and global colleagues to ensure compliance with regulations and company standards. We value people who are curious practical and committed to continuous improvement. Join us to grow your skills make a meaningful impact and contribute to GSKs mission of uniting science technology and talent to get ahead of disease together.

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

  • Ensure cGMP compliance in incoming material management warehouse manufacturing support and related QC testing operations.

  • Manage QA oversight activities including GMP record review housekeeping checks process confirmation and SOP compliance verifications.

  • Provide QA input for deviation / lab investigations CAPA implementation and change controls.

  • Manage material / supplier qualification in compliance with cGMP requirement and internal procedures.

  • Manage QA review and release of incoming materials and sterile buffers in compliance with cGMP requirement and internal procedures.

  • QA review and approve LSOPs checklists incoming material documentations deviations CAPAs change controls and quality tag outs in accordance with quality and compliance expectations.

  • Support site complaint investigations periodic quality review self-inspections risk assessments and/ or gap analyses corporate or regulatory inspections.

  • Mentor and coach junior QA staff to develop strong quality decisionmaking skills and ensure effective execution of qualityrelated tasks.

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

  • University degree in Science Engineering or a related discipline.

  • Minimum 5 years experience in Quality Assurance within the life sciences or pharmaceutical industry.

  • Practical knowledge of current Good Manufacturing Practice (cGMP) and Good Documentation Practice (GDP).

  • Hands-on experience with deviations CAPA change control and batch review processes.

  • Strong written and verbal communication skills and experience working with cross-functional teams.

  • Proficiency with quality systems and electronic document or training platforms. Experience with SAP is a plus.


Preferred Qualification
If you have the following characteristics it would be a plus

  • Bachelors degree in a relevant science or engineering field if your basic degree is different.

  • Experience with making quality decisions in a manufacturing setting.

  • Prior exposure to regulatory inspections and presenting to regulatory or corporate auditors.

  • Experience owning a site quality system or being a subject matter expert for a quality domain.

  • Familiarity with quality metrics trending and site-level quality council activities.

  • Project or change management experience supporting system implementations or process improvements.

To learn more about Singapore GSK and our people please click on this link: GSK

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 were 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 . 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 GSKs 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 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.


Required Experience:

Senior IC

You will support and lead quality assurance activities at our Singapore site. You will help maintain and improve our Quality Management System and support manufacturing training documentation and batch release activities. You will work with cross-functional teams and global colleagues to ensure comp...
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About us We are a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. We have 3 global businesses that research, develop and manufacture innovative pharmaceutical medicines, vaccines and consumer healthcare products.

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