Operational Quality Oversight

To ensure adherence to cGxP standards and procedures through the independent oversight of GxP processes. To improve the effectiveness of quality in preventing /identifying and addressing quality issues by encouraging proactive quality culture and continuous improvement. To maintain presence and be accountable for key quality decision-making or quality escalations. Required to perform 12-hour shift pattern (day shift).

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

• Ensure that all GMP processes and operational personnel adhere to current local or area specific procedures, minimising risk of non-compliance and maintaining inspection readiness at all times
• 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
• Authorise QA processes including changeover activities, quality tag out of equipment and facilities, buffer and material release, usage decision of inspection lot
• Perform a spot-check of activities across production, warehouse and laboratory areas to ensure compliance with quality standards that includes production, testing, cleaning and maintenance activities
• Ensure adherence to frequency of oversight mandated on Critical activities, records and data and GMP Exceptions as defined by risk assessment strategy or procedures for activities such as the review of CPP/CQAs and oversight of critical GMP alarms and audit trails
• Carry out real-time review of documentation and batch records ensuring that the content meets defined criteria, exceptions have been appropriately addressed and Good Documentation Practice (GDP) is being maintained following ALCOA+ principles for data integrity, audit and traceability.
• 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 remedial actions addressed within a timely manner. Support changeover of facility with change in product.
• Role model the GPS standards and 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

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

• Degree in Life Sciences, Chemistry, Engineering or a related discipline.

• At least 2 years of experience in a GMP-regulated manufacturing environment; experience in pharmaceuticals preferred.

• Practical knowledge of current Good Manufacturing Practices and quality systems.

• Experience with SAP or Veeva systems

• Experience supporting health authority inspections or major audits.

• Familiarity with risk assessment and quality risk management tools.

• Demonstrated ability to coach or mentor colleagues and to influence cross-functional teams.

• Strong written and verbal communication skills in English.

• Ability to review technical documentation and perform basic investigations.

• Comfortable working on-site and engaging directly with production teams.

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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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.

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