Job Title:Pharmacist in Charge Biotech GMP Light PartTime (JP10447 Location:Louisville KY 40201 Employment Type: Contract Duration: 9 months with likely extensions Posting Date:06/02/2022 Note: Shift/Hours: 24 hours every quarter for assessment 4 hours per month for trainings. Every 3 months preforming BOP assessments.
3 Key Consulting is hiring aPharmacist 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 onsite inspection of security and record keeping not less than quarterly.
Prepare in advance as needed to conduct onsite inspections.
At the conclusion of each onsite inspection prepare and deliver a written and signed report of the onsite 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
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