YOU will be responsible for supporting the establishment, validation, qualification & ongoing support of pharmaceutical cleanroom and all associates test programs.
YOU will provide microbiological support in the establishment of the Contamination Control Strategy & ongoing support to Operations, in ensuring operational goals & objectives are achieved for the plant.
This role plays a key part in establishing, maintaining & enhancing the Microbiological monitoring programs developed to ensure the sterility assurance of the product.
- Review and approve microbiological procedures, protocols, and reports. Support validation & engineering qualification activities.
- Provide support & technical expertise to ensure best practices.
- Support the development of the site strategy for cleanroom behaviors, aseptic practices & training of personnel.
- Lead and provide direction in all areas relating to the sterility assurance of the product.
- Microbiological systems & associated documents management.
- Provide expertise to other functions on quality-related issues e.g regulatory requirements, sampling principles etc.
- Evaluate quality events ensuring compliance with cGMP & quality standard requirements. Ensure timely & effective actions are implemented & CAPA effectiveness checks are conducted.
- Level 8 in Microbiology or a related discipline
- 3+ years’ experience within a pharmaceutical GMP environment, ideally within a Microbiological function.
- Working knowledge of FDA, HPRA & pharmaceutical industry microbiological requirements & associated manufacturing controls is desirable.
- Experience in problem-solving & process improvements is desirable.
- CAPA experience, Risk Management & Process Validation is also desirable.
For a confidential discussion on this or any other current job opportunity please contact Meggan on 021 235 9144 / email@example.com
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