Sample Resume-21.09.2012.doc

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D. Mallikarjuna Rao

Phone: +91-8886701090, 9441663108

E-Mail: [email protected]

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.

Academic Qualifications:

Course Institute / UniversityYear ofPassing

Percentage

M.Pharmacy(MedicinalChemistry)

Vinayaka Missions College of Pharmacy,Salem, TN.

2006 72 %

B.PharmacySri Padmavathi School of Pharmacy, Tirupati,

A.P.2003 66 %

Intermediate

(Bi.P.C) Ratnam College, Nellore, A.P. 1996 61%

S.S.C Ratnam High School, Nellore, A.P. 1994 72 %

Work Experience:

Industry Exposure:

Oral dosage formulation:

Organization Position held DurationTIL Healthcare Pvt Ltd,

Chennai, TNManager-QA July 2011 to till date

Orchid Healthcare,Chennai Assistant Manager -QA Jun 2010 to Jun 2011

Strides Arco Lab Limited(Onco Therapies Limited)

Bangalore

Sr.Executive, QADepartment

Dec 2007 to May 2010

Aurobindo Pharma Limited(Unit VI), Hyderabad, A.P.

Officer, QA Department(IPQA Activities)

Jan 2006 to Nov 2007

Aurobindo Pharma Limited(Unit VI), Hyderabad, A.P.

Trainee, QA Department(IPQA Activities)

July 2003- Jan 2004

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mailto:[email protected]:[email protected]


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D. Mallikarjuna Rao

Phone: +91-8886701090, 9441663108


Tablets & Capsules- Orchid Healthcare/ Aurobindo Pharma Ltd./TIL Healthcare

Pvt Ltd(From Project Stage).

Parental formulations:

Liquid & Lyo injections (Onco Division From Project Stage) - StridesArco 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, In-

process 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.

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D. Mallikarjuna Rao

Phone: +91-8886701090, 9441663108


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 self-

inspection 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 andensure 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 (Internaldept-Audits).

Ensure the regulatory agencies /Customers audit requirements.

Conducting the external audits (Vendor qualifications/Loan licensemanufacturing 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 (Changecontrols/Deviations/Incidents/Market complaints etc.).

Regulatory audit faced USFDA /MHRA

Review of all departmental SOPs.

Strides Arco lab Ltd.

Responsibilities:

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D. Mallikarjuna Rao

Phone: +91-8886701090, 9441663108


Preparation and Review ofBatch Manufacturing Records (BMR) &Batch Packaging Records (BPR) for sterile liquid injections(Including executed BMR and BPR).

Internal Audit.

Review ofStability data documents.

Ensuring documents issuance and documents archival as per theprocedure.

Review of BMR related attachments like Sterilization reports,

Manufacturing reports, Filter Integrity Reports (Pre & Post) and NVPC.

Review ofChemical (In process & Finished Product) and Micro(Bioload, BET& Sterility) documents.

Preparation ofMedia Fills Batch processing records and involved inmedia fill validations.

Handled 60 Exhibit batches from Dispensing to Packing (Onco products).

Assigning of product codes and Batch numbers. Preparation ofMaster Formula Records (MFR).

Preparation and Review ofProcess Validation Protocols and CleaningValidation Protocols.

Preparation Quality Assurance SOPS and Review of other departmentsSOPs (Production, Quality Control and Microbiology).

Review ofValidation documents.

Exposed to the following corners:Validations: HVAC, Bung Processor, Linear vial washing machine,

Tunnel Sterilizer, Filling machine for sterile powders andsterile 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:

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D. Mallikarjuna Rao

Phone: +91-8886701090, 9441663108


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) & BatchPackaging Records (BPR) for sterile dry powders

Expedient in computers

Operating systems Known: WINDOWS 2000/XP

Packages Known: Ms office

Mailing system: Lotus Notes & Internet

Personal profile:

Name: D. Mallikarjuna Rao

Fathers Name: D. NagaiahDate of Birth: 21-05-1979Marital Status: MarriedLanguages Known: Telugu, English & TamilPermanent 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,

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D. Mallikarjuna Rao

Phone: +91-8886701090, 9441663108


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 tothe best of my knowledge.

(D. Mallikarjuna Rao)

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Sample Resume-21.09.2012.doc

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