Pharmacy Quality Investigation Writer in ReviveRX

Overview: As an Investigation Writer at Revive Rx, you will play a critical role in ensuring the integrity of our pharmaceutical products by thoroughly investigating deviations, incidents, and complaints. The ideal candidate will have a strong background in technical writing, regulatory compliance, and investigative techniques within the pharmaceutical industry.Responsibilities:Conduct thorough investigations into deviations, non-conformances, complaints, and other quality events in accordance with established procedures and regulatory requirements.Gather and analyze relevant data, including manufacturing records, quality control data, and customer feedback, to identify root causes of issues.Collaborate closely with cross-functional teams, including Quality Assurance, Regulatory Affairs, Manufacturing, and Research & Development, to collect necessary information and implement corrective and preventive actions (CAPAs).Prepare comprehensive investigation reports that clearly, concisely, and accurately describe findings, root cause analysis, and proposed corrective actions.Ensure that investigation reports are completed within established timelines and submitted for review and approval by appropriate stakeholders.Participate in discussions and meetings to present investigation findings, discuss potential solutions, and support decision-making processes.Maintain accurate and up-to-date records of investigations, CAPAs, and related documentation in compliance with regulatory requirements and company policies.Continuously assess and improve investigation processes and procedures to enhance efficiency, effectiveness, and compliance.Qualifications:Bachelor's degree in Pharmacy, Chemistry, Biology, Pharmaceutical Sciences, or a related field.Minimum of 5 years of experience in technical writing, investigation, and quality assurance within the pharmaceutical industry.Strong understanding of FDA regulations and other relevant quality standards.Proven ability to conduct thorough investigations, analyze data, and identify root causes of quality events.Excellent written and verbal communication skills, with the ability to effectively communicate technical information to diverse audiences.Detail-oriented with strong organizational and time management skills to manage multiple investigations simultaneously and meet deadlines.Proficiency in Microsoft Office Suite and other relevant software applications for data analysis and report writing.Ability to work independently and collaboratively in a fast-paced, dynamic environment.Powered by JazzHRpsZ88j2ckt Show more Show less Должностной уровень Руководитель среднего звена Тип занятости Полный рабочий день Должностные обязанности Маркетинг, Связи с общественностью и Литературный и редакторский труд Отрасли Интернет-издательство