About the Role
:
Argenta is currently looking to fill the role of AS&T Analyst onsite at our Dundee location. This role will conduct non- routine Analytical Services for the site including (1) Analytical method transfers into Quality, (2) Analytical method evaluations and validation, (3) method innovation (4) pharmacopeial compliance, (5) sample management / logistics.
Key Accountabilities:
1. Evaluate the performance of analytical methods identifying continuous improvement opportunities
2. Performs method development and validation testing to maintain and improve the compliance status of the analytical methods used in the quality control labs.
3. Perform analytical method transfer testing required to successfully transfer analytical methods and techniques into the Quality control labs.
4. Perform analytical method verification activities to ensure that analytical packages are available and maintained to demonstrate Pharmacopeial compliance
5. Provide the analytical support for the Manufacturing Science and Technology group to support manufacturing process development & validation.
6. Provide analytical troubleshooting support for investigations which require non routine / specialized services
7. Comply with all company local and global policies including but not limited to Quality frameworks, Values and Behaviours and health, safety and environment (HSE) policies.
Perform any other duties or serve in such other capacity as may be determined by Company management.
Qualifications:
8. HNC or Degree in Science (Chemistry, Pharmacy, Chemical Engineering etc.)
Knowledge/Experience:
9. Minimum 1 year Experience in cGMP & Global regulatory environment
10. Ability to multi-task and adapt to changing business requirements in dynamic manufacturing environment
11. Demonstrated technology skills i.e. equipment, instrumentation & computers
12. Effective technical writing skills e.g. reports; SOPs and change control
13. 1 – 3 years experience - Proven track record in the performance of a variety of analytical techniques especially HPLC,
14. 1 – 3 years experience - Demonstrated experience in method development, method validation, troubleshooting and analytical technology transfer
15. Effective communication skills both written and verbal
Demonstrated continuous improvement mind-set