Senior Microbiologist-Consultant hourly rate
12-18 months
* Co-ordinate the preparation of micro protocols and reports for new products and modifications to existing products.
* Responsible for microbiological systems and associated documentation, ensuring they remain current and in compliance to regulatory standards and Corporate requirements.
* Participate in the internal and vendor auditing programmes.
* Product testing validations for endotoxin and bioburden method establishment
* Support steam sterilisation and associated qualification as required.
* Author, review and approve microbiological procedures, protocols and reports for establishment of Microbiological monitoring programs to cGMP requirements
* Support validation and engineering qualification activities (e.g cleaning validation)
* Ensure Regulatory compliance in area of responsibility to cGMP's of all medical device regulatory agencies (e.g. FDA and HPRA).
* Provide key support and technical expertise to the site to ensure people and technical skills are in place to implement new technologies and apply best practice in Microbiological techniques and systems.
* Support development of the site strategy for cleanroom behaviours, aseptic practices and training of personnel.
* Take the lead and provide direction in all areas relating to the sterility assurance of the product.
* Responsible for microbiological systems and associated documentation, ensuring they remain current and in compliance to regulatory standards and corporate requirements.
* Provide functional expertise to other support functions on quality related issues (e.g. regulatory requirements, statistical techniques, sampling principles).
* Establishes and cultivates a wide range of business relationships to facilitate completion of assignments. Participates in determining goals and objectives for projects.
* Evaluate nonconformance ensuring compliance with cGMP and quality standard requirements. Support root cause analysis, product impact assessments and corrective and preventative actions (CAPAs) for quality events. Ensure timely and effective actions are implemented and that CAPA effectiveness checks are conducted
Experience
* Third level qualification in Microbiology or related discipline.
* Ideally 5+ years experience within a medical device/ pharmaceutical GMP environment.
* Excellent interpersonal and communication skills with good leadership abilities.
* Strong Decision-making skills and ability to work on one's own initiative.
* Ability to work with minimum supervision.