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Quality Pharmacist
3 months ago
DescriptionAs part of the Quality Unit at FarmaKeio Outsourcing (FKO), the Quality Pharmacist assists the Quality Director in overseeing the accuracy and completeness of products manufactured at FKO by establishing/approving documentation and reviewing quality data throughout all units of FKO. This role is responsible for reporting and developing/reviewing documentation to verify proper Quality Management System implementation. The Quality Pharmacist provides direct oversight of the compounding of pharmaceutical products at FKO and shall be responsible for batch approval/rejection since regulations require compounding to be by or under the direct supervision of a licensed pharmacist.Reports to: Quality DirectorResponsibilitiesPerform and/or coordinate completion of:•Environmental monitoring and documentation e.g. personnel monitoring, air bioburden, surface bioburden, temperatures, and particle counts•Collect environmental monitoring samples as necessary•Train new Quality Unit staff•Record sterility testing results, aseptic technique qualifications, and media fill process validations•Prepare/revise operating procedures and specifications•Review/approve routine change control requests as designated•Verify that raw materials meet specifications limits•Oversee control of product labeling/label accountability•Recommend and/or implement improvements in streamlining processes and procedures in the areas of compounding, validation, change control, laboratory, and risk assessments•Use incident and Corrective and Preventive Action (CAPA) activities and processes to drive quality improvements and respond to process and service issues•Assist with root cause analysis and CAPA for audit observations, product complaints, product non-conformances, in-process deviations, and CAPA•Assist with the investigation of excursions in manufacturing or other related operations. Resolve the cause, impact on product quality, disposition, and corrective actions at the direction of the Quality Director•Perform final review of test data/reports to ensure conformance to the established specifications and standard operating procedures and perform final disposition of batches•Verify that product test results meet specification limits•Track vendor equipment calibration and maintenance records and assess for deviations•Assist the Quality Director with results of deviation and complaint investigations, quality-related events, causal analysis, corrective actions, and preventive actions•Maintain quality records (equipment calibration and maintenance, training, deviation, and complaint investigation, environmental monitoring, Certificate of Analysis, clean room certification)•Reciprocate Pharmacist License as necessary to comply with regulatory requirementsQualifications•BS Pharmacy or Pharm.D with registration in good standing and current pharmacist license in the state of Texas•Ability to work autonomously within established procedures and practicesWork Environment: Climate-controlled office environmentKnowledge & Skills•Working knowledge of Current Good Manufacturing Practices (cGMPs), FDA regulations (21 CFR Parts 210, 211), and ICH regulations•Effective communication skills, both written and verbal•Ability to act effectively as a member of a team to resolve problems•Good organizational and time management skillsPhysical and Special Requirements:•Ability to stand for prolonged periods of time•May need to lift, up to 40 pounds•Limited exposure to potentially hazardous substances
