Job Description
You will provide dedicated QA oversight and first-line quality support to manufacturing and quality control operation during shift and manage quality- related activities and escalations, including batch usage decision support, to maintain cGMP compliance in line with defined QMS requirements and regulatory standards.
Key Responsibilities
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
1. Quality Oversight
- Ensure GMP processes and operational personnel adhere to governing procedures, minimising risk of non-compliance and always maintaining inspection readiness.
Maintain presence across area of responsibility and be the first line of contact to support initial management of quality issues and be accountable for key quality decision making across activities such as the initial impact assessment for deviations.
Provide guidance during GMP activities to proactively detect potential quality issues through active observation in real-time, allowing for timely interventions to prevent deviations and defects.
Perform a spot-check of activities for the oversight areas to ensure compliance with quality standards.
Ensure adherence to frequency of oversight mandated in the Quality oversight schedule.
Review batch related documentation and records ensuring that the content meets ALCOA+ principles.
Check that facilities are being maintained in a good state in line with local housekeeping standards and any deviation from the standards are escalated with associated actions addressed timely.
Authorize campaign changeovers and participate in facility walkdown where required.
Participate production tier meetings to provide input to manage quality issues and follow up.
Foster a Quality Starts With Me (QSWM) culture by providing coaching to employees on the importance of following procedures, doing the right thing and explaining the why and the impact non-compliance can have on product quality and patient safety.
2. Authorization Activities:
- Authorize QA processes such as Quality Tagouts, conditional equipment releases, campaign changeovers, and room releases.
- Decide compliance status for QC testing, validation issues, batch usage, record closures, and processing or release suitability.
3. Documentation Review and Approval
- Review and approval of executed batch records and related checklists, and take batch usage decision for sterile buffers, bulk and / or drug substance intermediates as assigned.
- Review and approval of procedures, checklists, master batch reocrds, deviations, CAPAs, change controls, and quality tag out related to manufacturing operation as assigned.
4. Training and Subject Matter Expertise:
- Own and maintain relevant SOPs and checklists, train personnel, and support self-inspections and audits.
- Act as a subject matter expert (SME), implement quality process improvements, coach junior staff (for Senior position), and stay updated with best practices.
5. Other QA Support Activities:
- Support periodic quality product reviews and site key performance indicator (KPI) reporting.
- Perform internal audits and risk assessments/gap analyses as part of continuous quality improvement efforts.
Basic Qualification
We are seeking professionals with the following required skills and qualifications to help us achieve our goals
Bachelor's degree in life science, pharmacy, engineering, chemistry or related technical discipline.
Minimum 2 years of experience within pharmaceutical, biotechnology, medical device or related regulated industry for QA Executive.
Preferably 5 years of experience within pharmaceutical, biotechnology, medical device or related regulated industry for Senior QA Executive.
To demonstrate knowledge of GMP standards and regulatory requirements and display ability to effectively operate within the pharmaceutical quality systems.
User experience with Quality Management Systems (QMS) Ability to communicate effectively within the site
Ability to apply risk management skills and risk based approach adequately
Ability to apply quality assurance standards and to promote quality as a competitive advantage.
Ability to solve simple / lower impact investigation
To learn more about Singapore GSK and our people, please click on this link: https://www.linkedin.com/company/glaxosmithkline/life/gsksingapore
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Skills
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 [email protected]. Please note this email is for adjustment requests only; for other enquiries please use our standard contact channels.
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