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[QUOTE=Guest-IJT;102898]M. JANARDHAN
c/o Sivakumar goud,
H.No: 5-106/1, Opp: Sha theater,
HMT Road, Siva Nagar, Chintal,
Hyderabad – 500054. A.P.
Mobile: 09010070879, 09640555496, 09966340759.
Email: mjraurobindoqms AT gmail.com & januap.pharma AT gmail.com
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JOB OBJECTIVE
To employ my skill and talent with high orientation, to excel in the field of Quality control through a challenging career in a leading edge organization that will provide constant opportunities for growth and advancement.

ORGANIATIONAL DETAIL

Total Experience: 6 Years Areas of Interest: QA – Complies Dept /A- QA

- Currently associated with Aurobindo Pharma Ltd., Hyderabad [as Sr, Executive from 2006 to till date.,] engaged in manufacture of Antibiotic and Anti hormonal formulations like Tablets, Capsules, Liquid Orals Products and unit is Approved by USFDA, TGA, WHO, MHRA, ANVISA, etc.

- Worked as a Gland Pharma Ltd., Hyderabad [as Executive from 2004 to 2006] engaged in manufacture & export of pharmaceutical formulations like parental Products, Tablets, is approved by USFDA, ANVISA, TGA, WHO and Good parental company is Asia etc.
ACADEMIA
- M.Sc. Chemistry from Nagarjuna University, Guntur - A.P.
- M.Sc. Applied Microbiology from Periyar University, Salem – T.N.
- B.Sc. Chemistry from S.V.University, Tirupathi – A.P.
- 10+2 from A.P.R.J.College, Venkatagiri (Nellore) – A.P.
- S.S.C from A.P.R.School, Gandipalem (Nellore) – A.P.

JOB RESPONSIBILITIES

- At Aurobindo Pharma Ltd., Hyderabad:

- Empower Software, Daily Audit Trial review, Backup of the Chromatography data.
- Handling Laboratory Errors, deviation, PNC’s
- Carry out the Good Laboratory practices.
- Especially take care the Dissolution Profiles: Validation samples, Exbit and Bio batches
- Review and Approval of Product release documents: Especially quality control analytical reports {RM, FP, PV} and microbiology reports for a batch as a part of batch release.
- Audit complies & Dealing with Domestic and Export & Out side laboratories Customers, as per our Organization requirements.
- Self inspections and Internal Quality Audits and follow up with respect to the audit compliances.
- Reviewing of executed BMR/BPR and QC data for each batch of the product and give final release of the product
- Training on all QA related documents and cGMP training.
- Ensuring all operations in Production/QC/Stores are performed in accordance with the relevant SOP and cGMP guidelines
- Issuing and retrieval of controlled copies of SOP’s and specifications to respective user departments
- Preparing the General Standard operation procedures and testing procedures.
- Handling activities like OOS, Deviation, Change control, Market complaints and Internet audit.
- Register all “Market Complaints" and coordinate investigation activities with QC and prepare final report.
- Monitoring and sampling of process validation batches.
- Facing customer and regulatory audits and audit follow-ups.
- Preparation and Reviewing of QA related documents. Review of executed Batch Records and Bio Batch from R&D and Production and Batch Release.
- Line clearance at all critical stages.
- Handling of rejected / recalled materials.
- Identification & Justification of Retainable goods.
- QA (cGMP) rounds of critical areas and follow up with regards to the compliances
- Updating the pharmaceutical changes as per requirements.
- Attended the audits like USFDA, ANVISA, WHO, FDA, MHRA etc.,

- At Gland Pharma Ltd., Hyderabad:

- Preparation and Review of "SOPs, STPs, GTPs” and also all QC &QA- Documentation
- Monitoring of RM & PM Dispensing activities.
- Performing quality related functions as and when designated by the superior.
- Issuing of all Labels, SOP’S, GTPS, STPS
- Preparation of COA’S as per customer required
- Issue of BMR's, BPR’s, Batch numbers and log books / registers.
- Issue of Monthly formats to all departments and as when required
- Experience in preparing check list for each batch of product and ensure that all documents are in batch file, review all manufacturing, packaging records and analytical reports are complete and accurate which are previously reviewed and approved by respective departments before batch release.
- Handling of rejected / recalled materials.
- Identification & Justification of Retainable goods.
- Analysis of Finished & Raw Material & In process & Process samples.
- Checking of QC Instruments, Document issue and control.
- Operating of Q. C. Instruments HPLC, UV, KF Titrimeter, FTIR etc.
- Maintaining the detail records of all activities in the department.
- Co-ordination with related departments.
- Attended the audits like USFDA, ANVISA, WHO, FDA, MHRA etc.,
- Analyze the various Intermediates and Finished material as per pharmacopoeias and in- house standards.
- Wet lab Instruments can be calibrated and checked.
- Handled documentation requirements for USFDA, WHO, TGA, ANVISA, ISO Audit etc.

INSTRUMENTAL ACCESS

- Well versed with highly sophisticated Analytical instruments such as :

- HPLC : Agilent, waters
- UV-VIS : Shimadzu
- GC : Shimadzu
- FTIR : Shimadzu
- Karl Fischer (KF) : Methrohm
- Dissolution tester : Lab India & Distek and Electro Lab
- Hardness & Thickness : Pharma Test
- DT & Friability Int’s : Electro Lab

COMPUTER EXPOSURE

- Completed one year Diploma in Office Management in computer course & well versed with software packages such as MS - Word, MS - Excel, MS - Power point, Internet & E-mail.

PERSONAL INFO

- Date of Birth : 01 – 04 - 1981
- Permanent Address : B/o M.Veeraswamy MBA,
Banglathota – Village,
Nawabpet – Post,
Nellore – Rural,
Nellore – Dist.
- Blood Group : O+ve
- Religion : Hindu
- Marital Status : Married
- Languages known : Telugu,English, Hindi,Tamil.

DECLARATION
I hereby declare that the above given information is true to the best of my knowledge.

Yours faithfully

(M.JANARDHAN)[/QUOTE]

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