Our client, a leading global Medical Device organisation, are looking to recruit a Senior Analytical Development Chemist on a 12 month hourly rate contracting basis.
- Responsible for analytical method development and validation of cGMP compliant and state of the art methods.
- Develops and executes protocols for test method validation/transfer and equipment qualification.
- Ensures timely and right first time method transfer to/from CoE to Quality Laboratories, including the issue of protocols and reports.
- Responsible for assessing compliance of methods to the Pharmacopeias.
- Maintains a current understanding of regulations as applied to laboratories.
- Conducts laboratory investigations as necessary and issues the corresponding reports.
- Responsible for development, writing and updating of standard operating procedures.
- Troubleshoots analytical methods as needed to ensure proper functionality.
- Responsible for assuring adherence to local and national regulations, cGMP's, SOP's, company policies and procedures.
- Authors technical reports and regulatory supporting documents, as necessary.
- Keeps abreast of relevant new technologies / capabilities and regulatory initiatives / requirements.
- Maintains accurate laboratory information, which includes sample data for all tests performed.
- Works independently on complex issues (troubleshooting, review documents, recognize problems and implement process improvements).
- Responsible for calibration and maintenance of analytical equipment.
- Responsible for communicating project related issues or opportunities to management and project sponsors.
- Performs other related duties as required.
- Chemistry degree and 5+ years of relevant experience
- Expertise in HPLC, GC, and UV-vis methods development and validation
- Proficiency with GC-MS and validation
- Experienced with laboratory instrument qualification and troubleshooting
- Experienced in laboratory GMPs in pharmaceutical or medical device industry; Combination product familiarity preferred
- Experienced in cleaning validation
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