Siva Prasad Komali :
Flat no : 303
Maruthi Residency,
Jayanagar extn,
Opp : K.P.H.B.Colony,
Hyderabad-72
Email ID : sivakomali1811 AT gmail.com
Contact No. :+91 7702211238
Career objective :
Quest to work in real professional and competent atmosphere involving my enthusiasm aided with my efforts and contribution to the growth of organization.
Summary :
Pharmaceutical quality professional with a M.Sc., degree in Organic Chemistry and around 14 years of work experience in the pharmaceutical industry. These experiences focused extensively on Audits (internal and external), Change management utilizing a risk based approach, Operational Excellence utilizing tools such as FMEA & Quality by Design and root cause analysis. Review documents such asSOPs, Incidents, deviations, change controls, corrective and preventive action plans, validation protocols/reports, Stability studies, CMC submission to support filing of the drug substance & technical reports, etc., that are submitted to QA for approval. Interprets and implements quality procedures, manages quality systems and assists in facilitating regulatory compliance inspections. Have hands on experience with various instruments such as HPLC, GC, FTIR, UV-Vis, and Polarimeter.Have excellent understanding of Organic, inorganic, and Analytical chemistry. Have hands on experience to face various regulatory audits like USFDA, TGA, WHO, and customer audits.
Professional Experience :
Total 14 years’ experience in reputed organizations
Total 13 years in Dr.Reddy’s Laboratories.
Presently working in Quality Assurance Department as an Assistant Manager at Custom Pharmaceutical Services since May 2007
5.8 years’ experience in Dr.Reddy’s Laboratories as Sr.Executive in Quality Control Department from February 2001 to September 2006
Around one year experience in Hetero Drugs limited as Sr.Executive in quality control department from September 2006 to May 2007
Career achievements :
** Handled & successfully completed CPS customer audits, like GSK, Prana, Bayer, Schering Plough, Merck, Abbott, Prostrakan, Oxigene, Chugai, Rottapharm, Roche and J&J.
** Initiated and implemented development QA activities in CPS by keeping relevant quality systems in the development area and made the facility to in line with current quality system requirements against the practices.
** Developed 6 SBPs for making intermediates & APIs by ensuring cGMP compliance. This is possible because of provided more training sessions, timely guidance and routine audits.
** Carrying vendor audits to ensure the quality of Raw material and to develop the vendors. (~10 Vendor audits completed including API, raw materials & Intermediates mfg units)
** Developed M/S Vijayasri Organics about the system compliance following by continual monitoring and support to strengthen the systems by providing training and in-time quality decisions.
** Developed an In-house method, alternative to Ph.Eur method (purity by HPLC), which was approved by EDQM.
** Developed an In-house method by combining OVI and residual solvents by GC which was approved by EDQM.
** Active participation in successful completion of USFDA, TGA and MHRA.
Hands on experience in Quality Assurance :
Expertise in analytical assurance :
** Review of analytical method validation protocols and reports as per the regulatory requirements.
** Responsible for review & approval of analytical method validation/transfer documents.
** Review of stability study data as per ICH guideline and assign the re-test period.
Expertise in Vendor Management :
** Handling of vendor/SBP (Strategic Business Partners) management like periodical GMP audits, trainings, support on quality system implementation and investigations etc.
** Handling of vendor qualification management for new/existing vendors
** Carry out vendor audits to ensure the quality of Raw material/intermediates and to develop the new vendors.
Expertise in Quality Management system :
** Responsible for preparation, review and approval of Standard Operating Procedures (SOPs) in various departments to meet the regulatory requirements as well as the Quality Systems.
** Preparation of GMP training – schedule and its implementation
** Ensure internal audits are carried out as per the schedule and necessary corrective and preventive actions are taken
** Handling of OOS, incidents and Carryout investigations for root cause analysis and implementation of CAPA.
** Preparation of validation master plan, review and approval of validation protocols and reports.
** Handling of change control and ensures the all the changes are meeting the regulatory requirements.
** Responsible for the review of manufacturing batch production Records.
** Conducting internal audits as per schedule and monitoring of corrective and preventive actions
Expertise in establish quality systems at R&D centre :
** Coordinating technology transfer meets to absorb new product technology and document the details and monitoring of action items.
** Responsible to involve in the specification fixation for API/intermediates to in line with regulatory /ICH requirements.
** Well versed with giving Training sessions to development team and manufacturing team on the topics Impurities, specifications, stability studies, analytical method validation and GMP etc.
Expertise in customer and regulatory support :
** Handling customer queries and complaints.
** Responsible for responding to any regulatory queries on behalf of the project team with inputs form other team members
** Review of process development and analytical reports.
** Co-ordination for compilation of CMC support in connection to IND filings for NCE molecules.
** Interaction with customer by participating in the teleconferences
** Expertise in providing regulatory opinion and decision making on the following activities and providing guidance to development team and manufacturing team.
** Setting up of specifications (Key starting materials, Intermediates and API)
** Tracking of impurities right from the starting materials to API
** Cut-off study reports (Reagents, solvents, Impurities etc.)
** Qualification of Reference/working standards
** Qualification of impurities
** Reports (Polymorphism, Isomerism, Chirality)
** Structural Elucidation reports (Characterization of Impurities, API)
** Analytical method validations
Exposure in Quality Control Department :
** Performed analytical method validation for NCEs, API molecules by using HPLC/GC instruments for NDA, ANDA and FDA submissions.
** Developed robust and general analytical methods for intermediates and API molecules.
** Developed and validated Cleaning methods for various NCEs and High Potent molecules.
** Exposure in conducting stress study for API molecules and establishing the solid state stability and solution stability as per ICH guidelines.
** Calibration of instruments as per master calibration schedule.
** Good knowledge in Analytical Instrument Qualification procedures.
** Broad knowledge in gas and liquid chromatography, and spectroscopy theory and its techniques.
** Establishing recovery factor for cleaning methods.
** Handling of OOS and OOT analysis for API molecules.
** Contributing to the daily Analysis (like raw material, in-process and finished product samples, Maintaining the lab notebooks and written reports) and reporting the work plan accordingly.
** Proficient in MS Office (Word / Excel/Power point) Lotus notes and technical writing.
Prepared presentations and presented data and projected updates to senior management.
** Become expertise in handling various types of Instruments like GC, HPLC, FTIR, UV, and Polarimeter.
PERSONAL PROFILE :
Name : Siva Prasad Komali
Father’s Name : Rama Krishna
Date of Birth : 18-08-1977
Languages Known : Telugu, English and Hindi
Marital status : Married
Qualification : M.Sc., (Organic Chemistry) with 62% - Andhra University.
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