Shift Operational Quality Technician

Purpose

To provide quality oversight for manufacturing operations and ensure full compliance with current Good Manufacturing Practices (cGMP) and regulatory requirements, so as to meet stipulated product quality standards in line with the established specifications of the organization.

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
• Min 3 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

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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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