Pharmacy QA Specialist
PHARMACY QUALITY ASSURANCE SPECIALIST
· Designs customized audit and evaluation surveys and protocols to evaluate and validate equipment qualification and installation; computer systems validation; product recalls; error and accident reports; inspection protocols; document management; personnel training requirements; personnel competency assessments; and workplace safety and infection controls. After conducting evaluations and audits, prepares reports of findings, improvement and corrective action plans, inspection and assessment protocols, records management plans, and computer systems validations.
· Implements departmental policies for quality assurance activities to include SOP standards, validation, and implementation; equipment qualification and installation; computer systems validation; product recalls; error and accident reports; inspection protocol; document management; personnel training requirements; personnel competency assessment; and workplace safety and infection control.
· Reviews and recommends improvements to standard operating procedures (SOPs) and instructions for all quality activities to include the quality assurance plan, systems monitoring, internal auditing, and improvement and corrective plans.
· Identifies variances in procedures or guidelines/regulations which may have great impact on the safety of the drug supply and potential risk management (e.g., patient death, litigation, FDA licensure, professional accreditation) and improperly tested or labeled pharmaceutical products which if released to the public may impact on patient safety.
· Evaluates and advises on the approval/rejection of potential contract manufacturers and contract testing laboratories
· Reviewing training records to assure personnel are trained in good compounding practices (GCP) and/or good manufacturing practices (GMP). Ensures records and systems are in compliance with standards, regulations, policies, procedures and instructions by conducting reviews.