Biopharmaceutical Quality Assurance Specialist
5 days ago
We are seeking a skilled Biopharmaceutical Quality Assurance Specialist to join our team at 825 Glaxo Wellcome Manufacturing Pte Ltd. This is an exciting opportunity to work in a dynamic environment where you will be responsible for ensuring the quality of our biopharmaceutical products.
Job DescriptionThe successful candidate will be responsible for implementing and maintaining sterility assurance programs, providing QA oversight, and ensuring compliance with company policies and GMP expectations. You will also be accountable for the execution and maintenance of the Environmental Monitoring program and provide support to Value Stream in matters related to Sterility Assurance.
Key Responsibilities:- Implement sterility assurance program on site
- Review and approve gap/risk assessments relating to Sterility Assurance
- Provide QA oversight to Sterility Assurance for site manufacturing processes and products manufactured by the site
- Accountable for the execution and maintenance of the Environmental Monitoring program
- Provide support to Value Stream in matters related to Sterility Assurance
To be successful in this role, you will need:
- A university degree in relevant Science (microbiology preferred) or Engineering discipline.
- Experience in application of expertise and knowledge for the following domains: Bioburden & endotoxin control, Media Simulation, SHT & CCIT, Sterilisation Methods, VHP Changeover Cleaning Disinfection, Aseptic Practice, EM & Utilities, cGMP regulatory requirements, and Good understanding of regulatory inspection requirements.
- Good analytical and problem-solving skills, ability to take difficult and risk-based decisions based on available information, demonstrated professional and ethical integrity, fluency and proficiency in the English language, good writing skills, and ability to operate independently.
We offer a competitive salary of SGD $80,000 - $100,000 per annum, depending on experience. In addition to a comprehensive benefits package, including medical insurance, retirement savings plan, and generous paid time off.
About Us825 Glaxo Wellcome Manufacturing Pte Ltd is a global biopharma company dedicated to getting ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of 2030. Our success depends on our people, and we want GSK to be a place where people can thrive. If you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
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