|Reference # : ||18-09056
||Title : ||Pharmacist in Charge|
|Experience Level : ||
||Start Date / End Date : ||10/29/2018 / 10/15/2021
| Description |
|MAX RATE NOT TO EXCEED: $93.30|
1. Be responsible to the Client Louisville KY site head and Manufacturing area Management for the performance of their duties.
2. Be responsible to the Kentucky Board of Pharmacy (KBOP) for the security and record keeping of the Client Louisville KY drug manufacturing facility, per 201 KAR 2:230, Section 5 (link at http://www.lrc.state.ky.us/kar/201/002/320.htm)
3. Conduct an on-site inspection of security and record keeping not less than quarterly.
4. Prepare in advance, as needed, to conduct on-site inspections.
5. At the conclusion of each on-site inspection, prepare and deliver a written and signed report of the on-site inspection to the Client Louisville KY site head prior to departure.
6. Comply with all other applicable laws and regulations in connection with being the PIC at the Client Louisville KY site.
7. Comply with all regulatory or governmental agency reporting requirements two weeks in advance of deadlines.
8. Be available to answer questions or respond to comments from any applicable regulatory agency (FDA, KBOP, etc.) in a timely manner.
9. Respond to questions or comments from any applicable regulatory agency (FDA, KBOP, etc.) in a timely manner, after consulting with the Client Louisville KY site head.
10. Keep Client Louisville KY site head informed of all communications between any regulatory agency (FDA, KBOP, etc.) and the PIC