POTNURU SASIBHUSHAN

Quality Management Professional-Pharmaceuticals-Committed to excellence in all facets of Pharmaceutical product Quality compliance in accordance of FDA, MHRA, ICH and USP Guidelines. An experienced professional with over 20 years of successful work experience in pharmaceutical industry who is committed to ensuring quality in products, personnel and processes. Deliberate Quality Assurance Administrator with experience in quality improvement . User advanced communication skills to interact with colleagues from different departments.

• Achieved A, B & C certificates in NCC (Wing - Air Force) and participated in ALL National Level Training programs.
• Participated in various awareness programs during All India Pharmacy week celebrations conducted by Pharmacy Council of India (PCI).

• Expertise in the Handling of various regulatory audits like USFDA, TGA, KFDA, ANVISA etc.

• Self-motivated & self-disciplined with professional attitude and work ethics.
• Positive thinking and stay focused under pressure.
• Work to ensure personal and organizational reputation.
• Ability to work as a part of team and team lead with good leadership qualities.
• Quick Learner - Willingness to learn new ideas and concepts.
• A strong will power with desire to contribute and succeed.
• Good project management, time management and decision-making skills.

• Ensure adherence to the Quality Policy. Quality Management System (QMS), Standard Operating Procedures (SOPs), and GMP regulations at the site.
• Provide training and mentorship to the quality assurance team and other department personnel on procedures, regulatory guidance and GMP.
• Responsible for compliance verification and improvement of procedures across all the plant.
• Responsible for Handling of customer audits, organizing audit scheduler, providing customer responses.
• Preparation of Audit Responses to the Internal and External audits.
• Handle customer and regulatory queries, documents for regulatory filings.
• Review and/or approve various quality management documents, such as change controls, CAPA, Investigations, validation, specification, test methods etc.
• Management of Vendor qualification, conducting audits at various vendor sites (CTL)
• Resolving issues and providing suggestions to all other stack holders.
• Release of the product into the market as per the committed timeline.
• Responsible for the qualification of equipment, raw materials, packaging materials, and critical service providers for testing, calibration and validations.

• Father's Name: POTNURU LAKSHMANA RAO (Late)
• Date of Birth: 02/27/82
• Gender: Male
• Nationality: Indian
• Marital Status: Married
• Religion: Hindu

• Trained in Workshop regarding GMP, CGMP, GLP, GDP, Validation & Other aspects in AIPT institute (American institute of Pharmaceutical Technology).
• Certified at Knowledge tree Consulting for Reach for Excellence – A Leadership development program.
• Attended for two days training program on Extractables and Leachables study by CPhl at Hyderabad.
• Attended Training programs related to Chromatographic techniques, Elemental impurities risk assessment and advances in Analytical techniques.
• Completed Landmark Forum trainings.