Baxter provides a broad portfolio of essential renal and hospital products, including home, acute and in-centre dialysis; sterile IV solutions; infusion systems and devices; parenteral nutrition; surgery products and anaesthetics; and pharmacy automation, software and services. The company’s global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries. Baxter’s employees worldwide are building upon the company’s rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care.
- Ensure that all cGMP’s and CQP’s are followed at all times.
- Provide Day-to-day, ongoing microbiology & sterility assurance expertise and practical support to the sterilization process together with SA engineer
- Responsible to review and investigation a typical autoclave cycles and recommend status of affected loads
- Provide support to Quality Assurance team for the trend of atypical cycles and implement corrective action.
- Review impact of product, equipment, process change to sterilizer qualification status. Provide inputs and approve change controls affecting sterilization process.
- Review and assess the CWO in related to sterilizers and other intend equipment or system that would impact the bioburden and sterility of product.
- Provide effective management of projects impacting sterilization process and related utilities to ensure that all work meets standards and other requirements.
- Ensuring compliance to the Baxter Quality Management System (1QSys) related to Sterility Assurance; aligned with Global Quality requirement
- Represent Amata plant as the Sterility Expertise Council Representative for the AP region SA Quality System Element
- Perform and / or support sterilizer qualification
- Perform microbiology testing of Finished Product, Raw Material and Stability Samples.
- Maintain laboratory and facility in a clean and orderly fashion as 6S requirement.
- Update and prepare standard operating procedure as related to microbiological testing.
- Adhere to Corporate quality procedures, Plant procedures, current Good Manufacturing Practices and safety standards at all times to maintain high scientific quality.
Who Can Apply:
- Bachelor degree in Microbiology, Biotechnology or related science
- Minimum 5 years experiences in microbiological laboratory in a pharmaceutical manufacturing environment
- Possess knowledge in GMP, ISO 9001, sterility testing, method validation and GLP in a pharmaceutical manufacturing environment will be an advantage
- Research and analytical skills for investigating issues and analyzing trends
- Good command of English
- Flexibility in working hours