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Quality Assurance Manager

Location:
Hyderabad, Telangana, India
Salary:
500000 CTC/annum
Posted:
October 06, 2016

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Resume:

RESUME

BIBHUDATTA PRADHAN

House No.:**-**/*/1

Street No.:6

Madhura Nagar, Shamshabad

Hyderabad - 501218

Mob. No: +91-789******* / 988-***-****

e-mail: acwx05@r.postjobfree.com

PROFILE

Diligent & result-oriented Quality Assurance Professional, M. Pharm (Pharmaceutical Chemistry) with 5 years of experience in Pharmaceutical industry in the area of Solid Dosage Form.

All-round competencies in Quality Assurance domain including all aspects covering – RA Supporting for ANDA Submission, Review & Compliance of Exhibit batch documents, Review of Stability Compilation Data, Preparation & Review of Validation Protocols & Reports & Stability Protocols, In-Process Quality Assurance, Documentation, Dispatch Activity, Change Controls, Deviations, Self-inspection, Preventive Maintenance, Preparation & Review of Annual Product Review.

PROFESSIONAL CHRONICLE

Hetero Labs Limited : As QA Executive from Oct.2014 to till date reporting to Sr. Manager MR K. Srinivas Rao.

RA Chem Pharma Ltd : As QA Executive from Dec.2011 to Oct.2014 reporting to Manager MR Sudhakar Reddy.

Cosme Pharma ltd : As QA Chemist (R&D) from Oct.2008 to Jul.2009 reporting to Manager MR D. Kulkarni.

CURRENT JOB RESPONBILITIES

To play a midlevel role between QA & Regulatory Affairs for ANDA submission.

Review & complies of Batch cards like BMRs & BPRs of Exhibit Batches.

Review of Analytical reports such as Raw material reports, Packing material reports, In-process reports, Process validation reports, Hold time study reports, Stability reports & Finished reports.

Preparation & review of Process Validation Protocols and Reports, Hold Time Study Protocols and Reports & Stability Protocols for Exhibit Batches.

Responsible for Execution & In-process activity of exhibit batches.

Review of stability compilation data for exhibit batches.

Review of comparative dissolution protocol & report of exhibit batches.

Review of method transfer / method verification of API of exhibit batches.

Review of method validations & method transfer of exhibit products.

Preparation of Risk Assessment protocol.

Arrangement of samples to address regulatory deficiencies.

Extreme Co-ordination with PD & QC for Technical data collection & get it completed before submitting to RA.

Extreme Co-ordination with various departments such as Fr&D, Ar&D, QC & PD for getting various technical documents required for submission purpose.

Assessment & Evaluation of critical data/parameters for departments Fr&D, Ar&D, QC, PD & QA

Provide support to RA for product wise global filing(US, EUR, ROW & WHO)

PREVIOUS JOB RESPONBILITIES

Ensuring cGMP (current Good Manufacturing Practices) and required Standard Operating Procedures to be followed during manufacturing and packing of the drug product.

Review of manufacturing/Packing record to assure that all in-process checks, reconciliation & entries are compliance with specification and regulation.

Performing internal audits as per schedule to ensure the quality system, and manufacturing followed as per cGMP.

Have Good Knowledge about Ware House (Packing & Raw materials) Activities like sampling, Dispensing & Receipt of Raw materials & Packing material.

Calibration of IPQA instruments.

Collection of Retention and Stability samples and also hold time study samples.

Issuance and Retrieval of monthly formats, Work sheets and Batch records to the concerned Department.

Issue of Protocols, Specifications and SOPs to the concerned department.

Preparation of Labels and review of Dispatch COAs

Review of Batch release certificates and arrangement of documents i.e. MSDS, TSE-BSE Declaration, WS COAs, MOA, Stability data etc.

Collection of Market samples and pre-shipment samples as per customer requirement.

Handling of Change controls and Deviations and monitoring of CAPA.

Preparation of Self inspection Schedule, Report and follow up actions as per CAPA.

Review and compliance of preventive maintenance checklist for utilities, general equipment and process equipment as per the schedule.

Preparation and review of Annual products.

AUDIT EXPOSURE

Actively involved in Regulatory Audits like USFDA, MHRA, COFEPRIS & HEALTH CANADA having individual role for each at RA Chem Pharma Ltd.

Customer Audits i.e. Vita Health Products, Orbicular Pharmaceutical, Riyadh Pharma, Novartis, Mylan, Emcure, Morningside Healthcare, Ilko Pharmaceuticals, Belupo, Deawoong, Devaholding etc.

PROFESSIONAL QUALIFICATION

M. Pharm (Pharmaceutical Chemistry) S.J.C.P.S, Naharkanta under BPUT, Rourkela.

B. Pharm I.G.I.P.S, Bhubaneswar under BPUT, Rourkela.

PERSONAL DETAILS

Name : BIBHUDATTA PRADHAN

Father’s Name : CHAKRADHAR PRADHAN

Date of Birth : 01-07-1984

Gender : Male

Marital Status : Married

Language Known : Oriya, English & Hindi

Permanent Address : At/Po: Arkil, Rengali Dyam Sait, Talcher

Dist: Angul ODISHA – 759100

DECLARATION

I hereby declare that the above furnished information is true and correct to the best of my knowledge.

Date : 07/09/2016 Sign : Bibhudatta Pradhan



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