amita pandey

RESUME – AMITA____________________________________________________________________________________________________Address:185 j lukerganj AllahabadMobile: +91-9057606589 (Calling time 6.00PM to 8.45AM )E-mail: [email protected] _____________________________________________________________________________________________________

Qualification: M. Pharm (Drug Regulatory Affair) from NRI Bhopal M.P. (RGPV University) in year 2015 Result

awaited. B. Pharm from A.P.I.T.C.E. Artoni Agra (G.B. Technical University) in year 2012 with 74.68% marks. Intermediate from Govt Girls Int. College, Allahabad in year 2003 (U.P BOARD). High School from VD Balika Int. College, Allahabad in year 2001 (U.P. BOARD).

Experience Summary: (Total Exp.-3 Year Approx. )CTD Dossier preparation, Exposed with the Quality Management System of large-scale drug manufacturing in formulation of Tablets, Capsules, Dry syrup, External preparations (Ointment). Have hands on experience of developing and reviewing of SOPs, STPs, Specifications, BMRs, BPRs, Validation Protocols, Reports and Batch Documents in the great sense with latest trends of developed market requirements at present scenario.

Experience Profile:M/S Gracure Pharmaceuticals Ltd. (Bhiwadi) Rajasthan. EU GMP, TGA, WHO Certified. It is having, Tablet & Hard gel capsule, Ointment, Liquid, Dry Syrup. It is DRUG REGULATORY Plant .

Duration: From 02 FEB.2015 to till Date.Position Held: Executive (QA).

Responsibilities: cGMP and need based training Co-ordinator. Responsible for Quality Audit Internal & External (as per EU GMP, TGA, WHO GMP ). Responsible for implementation of cGMP. Preparation of all kind of master document e.g. MFR,

BMR, BPR, SMF, SOP etc. Preparation & Review of APQR by compiling the trend data of in process, intermediates & Finished. Handling of Investigations, Change Controls, Deviations and Market Complaints. Preparation of List of Authorized Signatories. Artwork processing & approval. Process validation Protocol and Report.

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RESUME – AMITAM/S IDPL (Indian Drugs & Pharmaceuticals Limited) Gurgaon Plant (HR).It is a well-established pharmaceuticals manufacturer A Govt. of India Undertaking.Duration: From 31 Jan2014 to 31. Jan2015 ( 1 Year)Position Held: Tech. Supervisor (QA).

Responsibilities: Preparation of Drug Master File. Handing of all QA activities . Handing of Quality matters of Shop floor (IPQA). Handling of Validation & Equipment Qualifications (URS, DQ, IQ, OQ and PQ). Responsible for implementation of cGMP. Preparation & review of all kind of master document

e.g. MFR, BMR, BPR, SMF, SOP etc. To review and closure verification of Change controls, Deviations and Out of specifications. Allocation of product code to new products. Artwork processing & approval.

M/S ACCENT PHARMA, Bari – Brahmana, Jammu (J&K).Unit of The Madras Pharmaceuticals, having Tablets, Capsules and Ointment sections and doing Third party manufacturing on P2P basis.Duration: From Feb. 2013 to Jan. 2014. (Approx. 1 Year )Position Held: QA – Chemist Responsibilities: To ensure that stocks levels of all the products are maintained as per stacking norms & material

principle (FIFO) are followed /implemented. Accountability of finished goods according to BPRs. Preparation & Review of APQR by compiling the trend data. To coordinate with the project department for up-gradation of new facilities.. Issuance, checking & retrieval of Batch Processing records. Allocation of product code. Release of Finished goods for dispatch. Maintaining all quality documents. Looking after Stability cell independently for stability study

Monitoring Stability Studies: i. Collection and Loading of Samples in Stability chambersii. Sample withdrawal for analysis as per scheduleiii. Schedule preparation of new products.

Preparation of stability protocols and reports as per results obtained from QC.

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RESUME – AMITA

M/S EASTERN HEALTHCARE , SIDCUL HARIDWAR, (U.K).It is India’s leading pharmaceutical manufacturer of Softgel.Duration: From June 2012 to Jan.2013 (Approx. 7 Months)Position Held: Officer (IPQC).

Responsibilities: Sampling of Bulk, Intermediate and Finished Goods. To coordinate in the preparation and

conduction of internal audits. Dispensing of Raw and Packing materials. To review and closure of Change controls, Deviations and Out of specifications. Control samples arrangement, monitoring & recording. Reconciliation of APIs/Packing materials. Line clearance activities in all operational areas. Packing material testing and Release. To assurance online documentations during production and packing activities.

Professional Exposure: 1. CTD Dossier preparation, Artwork Approval.2. Development and review of Documents like SOPs, STPs, Specification, BMRs, BPRs, Checklists to

ensure the cGMP compliance.3. Management of cGMP Training.4. Handling of Self-Inspections and monitoring recommended Corrective and Preventive Actions

(CAPAs) to appraise the Q.A. systems.5. Equipment Qualification (URS, DQ, IQ, OQ and PQ) of Processing Equipments. 6. Validation activities like:

a) Process Validation

Audit Faced: WHO, UK, China, Various third party Customer audits like Lupin, Wockhardt, Sandoz, USV, Abbott, Ranbaxy, Blue Cross, Torrent etc.

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RESUME – AMITA

Personal Profile:Father’s Name : Sh. Brahm Dutt Pandey

Permanent Address : 185 j Lukerganj Allahabad Language : English, Hindi

Notice Period : One Month

DECLARATION:I hereby solemnly declare that the above furnished all information are true to the best of my knowledge and belief. Date:Place: (Amita)

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