D.

Mallikarjuna Rao Phone: +91-8886701090, 9441663108

E-Mail: malli_mpharm@rediffmail.com
Professional Summary: 7.9 years of rich experience in Quality Assurance Department. Excellent educational background with M.Pharm. Well versed in Pharma Standards and industry practices. Preparation and Review of BMR and BPR - Paranterals and Orals formulations. Ensuring cGMP compliance in Production. In Process checks during Manufacturing and Packing. Handling of the Quality documents (Change Controls / Deviations /Incidents/Market complaints) Audit & Compliance (Internal/External/Regulatory Agencies/Customers). Vendor qualification for Raw/packing materials. Excellent interpersonal skills and smart working. Commitment to Co-operative team works. Take pride in doing a good work and achieving good results.
Year of Passing 2006 2003 1996 1994 Percenta ge 72 % 66 % 61% 72 %

Academic Qualifications:
Course M.Pharmacy (Medicinal Chemistry) B.Pharmacy Intermediate (Bi.P.C) S.S.C Institute / University Vinayaka Missions College of Pharmacy, Salem, TN. Sri Padmavathi School of Pharmacy, Tirupati, A.P. Ratnam College, Nellore, A.P. Ratnam High School, Nellore, A.P.

WorkExperience:
Organization TIL Healthcare Pvt Ltd, Chennai, TN Orchid Healthcare, Chennai Strides Arco Lab Limited (Onco Therapies Limited) Bangalore Aurobindo Pharma Limited (Unit VI), Hyderabad, A.P. Aurobindo Pharma Limited (Unit VI), Hyderabad, A.P. Position held Manager-QA Assistant Manager -QA Sr.Executive, QA Department Officer, QA Department (IPQA Activities) Trainee, QA Department (IPQA Activities) Duration July 2011 to till date Jun 2010 to Jun 2011 Dec 2007 to May 2010 Jan 2006 to Nov 2007 July 2003- Jan 2004

IndustryExposure: Oral dosage formulation:

D. Mallikarjuna Rao Phone: +91-8886701090, 9441663108

E-Mail: malli_mpharm@rediffmail.com
Tablets & Capsules- Orchid Healthcare/ Aurobindo Pharma Ltd./ TIL Healthcare Pvt Ltd(From Project Stage). Parental formulations: Liquid & Lyo injections (Onco Division From Project Stage) - Strides Arco Lab Ltd. Dry powders - Aurobindo Pharma Ltd. Work details: TIL Healthcare Pvt Ltd. Responsibilities: 1. Overall In charge for Total Quality management system for all operations having an impact on quality of the process and final product. 2. Responsible for coordination and compliance for various regulatory inspections. 3. Responsible for the review and approval of plant documentation, compilation for submission to regulatory requirements. 4. Responsible to coordinate the plant management quality review meetings and Site transfer of technology. 5. Responsible for assessment and final approval of all Change Controls and monitoring of changes. 6. Responsible for the final approval of the product for dispatch after reviewing all the quality records. (Batch Manufacturing and packing Records, Inprocess Quality Control records, COAs, and other related batch records like deviation/investigation reports). 7. Responsible for the coordination of the cGMP and on the job training of the plant personnel. 8. Responsible for the initiation, review and assessment and final approval of deviations, non-conformances, Out of specifications. 9. Responsible for monitoring of all quality related activities and for the review & approval of Annual product quality review documents. 10.Responsible for the approval of the standard operating procedures, standard testing procedures, General Testing Procedures, Validation protocols, Master Formula Records, batch records (BMR,/BPR) and all other Master documents viz., Site Master File, Validation Master Plan, Training Manual and Quality Manual . 11.Responsible for total documentation control through proper change control system. 12.Responsible for the approval of validation studies of the process/Cleaning/Facility/Equipment/Instrument.

D. Mallikarjuna Rao Phone: +91-8886701090, 9441663108

E-Mail: malli_mpharm@rediffmail.com
13.Responsible for the approval of investigation and findings of market complaints. 14.Responsible for the coordination incase of product recalls. 15.Responsible for the GMP monitoring in the plant and approval of selfinspection reports. 16.Responsible for the timely updation of the documents on -line with the current regulatory guidelines. 17.Co-ordination with QC, packaging development and marketing departments for generation and approval of artwork. 18.Responsible to review and Approve the technical Agreements. 19.Responsible for the identification of Crisis situation, act accordingly and ensure compliance. 20.Periodic assessment of the vendors through vendor audit and vendor approval. 21.Joint responsible with General Manager Plant operations in monitoring and control of manufacturing environment, plant Hygiene and GMP compliance in the plant. 22.Joint responsible with Manager QCIn assessment and conclusion of stability studies. Audits Faced: GMP inspection & WHO audit, NDA (UGANDA) audit

Orchid Healthcare. Responsibilities: Conducting the self inspection of cross functional departments (Internal dept-Audits). Ensure the regulatory agencies /Customers audit requirements. Conducting the external audits (Vendor qualifications/Loan license manufacturing sites). Reviewing of Quality releated Technical agreements. Reviewing of Qualifications documents (IQ/OQ/PQ). Reviewing of Cleaning/Process validation related documents. Reviewing of all quality related documents (Change controls/Deviations/Incidents/Market complaints etc.). Regulatory audit faced USFDA /MHRA Review of all departmental SOPs. Strides Arco lab Ltd. Responsibilities:

D. Mallikarjuna Rao Phone: +91-8886701090, 9441663108

E-Mail: malli_mpharm@rediffmail.com
Preparation and Review of Batch Manufacturing Records (BMR) & Batch Packaging Records (BPR) for sterile liquid injections (Including executed BMR and BPR). Internal Audit. Review of Stability data documents. Ensuring documents issuance and documents archival as per the procedure. Review of BMR related attachments like Sterilization reports, Manufacturing reports, Filter Integrity Reports (Pre & Post) and NVPC. Review of Chemical (In process & Finished Product) and Micro (Bioload, BET & Sterility) documents. Preparation of Media Fills Batch processing records and involved in media fill validations. Handled 60 Exhibit batches from Dispensing to Packing (Onco products). Assigning of product codes and Batch numbers. Preparation of Master Formula Records (MFR). Preparation and Review of Process Validation Protocols and Cleaning Validation Protocols. Preparation Quality Assurance SOPS and Review of other departments SOPs (Production, Quality Control and Microbiology). Review of Validation documents. Exposed to the following corners: Validations: HVAC, Bung Processor, Linear vial washing machine, Tunnel Sterilizer, Filling machine for sterile powders and sterile liquids (cRABS). Aseptic media fill validations. QA Systems: Change control & Deviation/Incident control. Liaison with various departments like R&D, QC and Production QA round for cGMP compliance and quality checks in all production areas, QC and Micro. Played an active role for ANDA DMF filing of the following products (USA & Global market): Carboplatin Injection Irinotecan Injection Cisplatin Injection Oxaliplatin Injection Gemcitabine HCl for Injection Epirubicin HCl Injection Topotecan for Injection Doxorubicin HCl Injection Vinorelbin Injection Regulatory Audits Faced: USFDA Audit

Aurobindo Pharma Limited Responsibilities:

D. Mallikarjuna Rao Phone: +91-8886701090, 9441663108

E-Mail: malli_mpharm@rediffmail.com
Preparation and Review of Batch Manufacturing Records (BMR) & Batch Packaging Records (BPR) for sterile dry powder injections Preparation of Master Formula Records (MFR) Preparation of Process Validation Protocols Preparation of SOPs Participation in Internal Audits Assigning of product codes and Batch numbers Regulatory Audits Faced: USFDA, ANVISA (BRAZIL) Audits.

Aurobindo Pharma Limited Responsibilities: Monitoring of processing and packing activities of sterile dry powders In process control of Sterile powders Giving line Clearance to processing and packing activities of sterile dry powders Execution and review of Batch Manufacturing Records (BMR) & Batch Packaging Records (BPR) for sterile dry powders

Expedient in computers Operating systems Known: Packages Known: Mailing system: Personal profile: Name: D. Mallikarjuna Rao Fathers Name: D. Nagaiah Date of Birth: 21-05-1979 Marital Status: Married Languages Known: Telugu, English & Tamil Permanent Address: S/o. D. Nagaiah, Beside Kaladhar Complex, Teachers colony, Venkatagiri Town, Nellore (Dist) - 524 132, Andhra Pradesh. INDIA. Current Address: D.MallikarjunaraO, D.No.#2C, WINDOWS 2000/XP

Ms office Lotus Notes & Internet

D. Mallikarjuna Rao Phone: +91-8886701090, 9441663108

E-Mail: malli_mpharm@rediffmail.com
Kalinga Appartment, Park Street, Sulluru Pet, Nellore Dist, Andhra Predesh. INDIA.

Declaration: I hereby state and declare that the particulars given herein above are the true to the best of my knowledge. (D. Mallikarjuna Rao)