Pharmacist in Charge, Biotech GMP – Light Part-Time (JP10447)

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 [email protected].  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.