Quality Assurance Pharmacist
4 weeks ago
As a key member of the Quality Unit at FarmaKeio Outsourcing (FKO), the Quality Pharmacist plays a crucial role in ensuring the accuracy and completeness of products manufactured at FKO. This involves establishing and approving documentation, reviewing quality data, and reporting on the implementation of the Quality Management System.
Responsibilities:
- Perform and/or coordinate completion of environmental monitoring and documentation, including personnel monitoring, air bioburden, surface bioburden, temperatures, and particle counts.
- Collect environmental monitoring samples as necessary.
- Train new Quality Unit staff on quality procedures and protocols.
- Record sterility testing results, aseptic technique qualifications, and media fill process validations.
- Prepare and revise operating procedures and specifications to ensure compliance with regulatory requirements.
- Review and approve routine change control requests.
- Verify that raw materials meet specifications limits.
- Oversee control of product labeling and label accountability.
- Recommend and implement improvements in streamlining processes and procedures in areas such as compounding, validation, change control, laboratory, and risk assessments.
- Use incident and Corrective and Preventive Action (CAPA) activities to drive quality improvements and respond to process and service issues.
Requirements:
- Bachelor's degree in 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 practices.
Work Environment:
FarmaKeio Outsourcing is a climate-controlled office environment.
Knowledge & 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 skills.
Physical and Special Requirements:
- Ability to stand for prolonged periods of time.
- May need to lift up to 40 pounds.
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