Posted Date: Dec 16 2024
Purpose:
To ensure that supplier quality, outsourcing, products manufactured, and periodic review are in 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
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
At least an honors degree in a relevant science discipline.
Fresh Graduate or minimum 1 year of experience in pharma industry
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 conflict 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 special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
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