Prashanth Boini Email & Phone Number

Prashanth Boini is a QA Associate at 4C Pharma Solutions.

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  Qa Associate

  4C Pharma Solutions

  Aug 2023 - Present - Hyderabad, Telangana, India

  1. Quality Management Systems (QMS): - Ensure compliance with QMS guidelines for document control. - Maintain quality documentation in line with regulatory standards such as ICH GCP and GVP.2. Information Security Management Systems (ISMS): - Maintain confidentiality and integrity of PV data in accordance with GDPR and HIPAA standards. - Ensure data protection and information security compliance..3. Documentation and Reporting: -Prepare, review… Show more 1. Quality Management Systems (QMS): - Ensure compliance with QMS guidelines for document control. - Maintain quality documentation in line with regulatory standards such as ICH GCP and GVP.2. Information Security Management Systems (ISMS): - Maintain confidentiality and integrity of PV data in accordance with GDPR and HIPAA standards. - Ensure data protection and information security compliance..3. Documentation and Reporting: -Prepare, review, and manage Standard Operating Procedures (SOPs), work instructions, and other quality-related documents. -Collaborate with cross-functional teams to ensure accurate and compliant documentation across projects.4. CAPA Management : - Track the effectiveness of CAPA plans through metrics and follow-up audits. - Identify non-conformances and deviations, leading investigations to determine root causes.5. Customer and Patient Safety : - Ensure that all pharmacovigilance activities prioritize patient safety. - Address any safety concerns promptly and effectively.6.Internal Audit: - Conduct regular internal audits to evaluate compliance with SOPs, regulatory standards, and company policies. Show less