- JN -012024-1954393
- Jan 19, 2024
Senior Microbiologist with strong technical experience within the Pharmaceutical industry required to drive product transfer and validation and act as a Microbiology SME.
Key Roles & Responsibilities:
- 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.
- Microbiology lead for the contamination control strategy and establishment of such.
- Lead utility and cleanroom qualifications as Microbiology lead
- Product testing validations for endotoxin and bioburden method establishment
- Support steam sterilisation and associated qualification.
- Contribute to the Site Quality Management Review Process.
Education & Experience:
- Third level qualification in Microbiology or related discipline.
- Ideally 5+ years' experience within a 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.
- Experience in the pharmaceutical industry and GMP manufacturing with specific experience in the Microbiology function.
- Working knowledge and understanding of FDA, HPRA, and the pharmaceutical industry microbiological requirements and associated manufacturing controls.
- Experience in problem solving and process improvement methodologies
- Process Validation, Risk Management, CAPA experience.
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
- Consultant | Life Sciences & Engineering Recruitment