Job Title: Pharmacist in Charge, Biotech GMP – Light Part-Time (JP10447)
Location: Louisville, KY, 40201
Employment Type: Contract
Duration: 9 months with likely extensions
Posting Date: 06/02/2022
Note: Shift/Hours: 2--4 hours every quarter for assessment, 4 hours per month for trainings. Every 3 months - preforming BOP assessments.
3 Key Consulting is hiring a Pharmacist in Charge for a consulting engagement with our direct client, a leading global biopharmaceutical company.
Job Description:
- Be responsible to the company Louisville KY site head and Manufacturing area Management for the performance of their duties.
- Be responsible to the Kentucky Board of Pharmacy (KBOP) for the security and record keeping of the Louisville KY drug manufacturing facility, per 201 KAR 2:230, Section 5
- Conduct an on-site inspection of security and record keeping not less than quarterly.
- Prepare in advance, as needed, to conduct on-site inspections.
- At the conclusion of each on-site inspection, prepare and deliver a written and signed report of the on-site inspection to the site head prior to departure.
- Comply with all other applicable laws and regulations in connection with being the PIC at the manufacturing site.
- Comply with all regulatory or governmental agency reporting requirements two weeks in advance of deadlines.
- Be available to answer questions or respond to comments from any applicable regulatory agency (FDA, KBOP, etc.) in a timely manner.
- Respond to questions or comments from any applicable regulatory agency (FDA, KBOP, etc.) in a timely manner, after consulting with the site head.
- Keep site head informed of all communications between any regulatory agency (FDA, KBOP, etc.) and the PIC
Why is the Position Open?
backfill- handover
Top Must-Have Skill Sets:
- licensed pharmacist in the state of Kentucky
- Proficient in the BOP requirements per 201 KAR 2:230, Section 5 (link at http://www.lrc.state.ky.us/kar/201/002/320.htm) - Board of Pharmacy chapter for requirements.
- Great interpersonal skills; communication, etc
- Familiar GMP environment
- Computer efficient
Red Flags: No valid Pharmacist license in KY
Interview process:
Video Conference
We invite qualified candidates to send your resume to recruiting@3keyconsulting.com. If you decide that you’re not interested in pursuing this position, please feel free to look at the other positions on our website www.3keyconsulting.com/careers. You are welcome to also share this opportunity with anyone you think might be interested in applying for this role.