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regulatory affairs

Location:
Hyderabad, Telangana, India
Salary:
as per your organisation norms
Posted:
December 23, 2015

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Resume:

Dear Sir/Madam,

I Ch.Laxma Reddy, having * year 6 months of experience in the field of Pharmaceutical Regulatory Affairs, currently working as Regulatory Affairs - Executive in Indian Immunologicals Ltd (Central Govt.)

I acquire my experience in the functions of Preparation and submission of dossiers, in process Quality Assurance, Documentations in injectables. I have imbibed the work ethics, values and systems of the Organization. Therefore, my contribution to the organization, where I have worked has been meaningful, substantial and professionally contributing.

Hereby I have furnished my profile for your perusal and hoping to have a suitable position in your esteemed organization.

Regards,

Ch.Laxmareddy.

CURRICULUM VITAE

CH.LAXMA REDDY Email:acsv82@r.postjobfree.com RA Mobile: +91-970*******

OBJECTIVES

To pursue a challenging career in the field of Generic Pharmaceutical Regulatory affairs and be a part of a progressive organization that gives scope to enhance my knowledge, skills and reach pinnacle in this field with sheer determination, dedication and hard work.

PROFESSIONAL EXPERIENCE:

Gland Pharma Limited Hyderabad, Quality Assurance Chemist, Since {July-2011 to November-2013}

Gland Pharma is the first USFDA and WHO approved Parenteral facility in India. Gland Pharma is well known for manufacturing of high quality sterile formulations.

Zenotech Laboratories Ltd, Hyderabad, as RA Executive from (Dec-2013 to May-2014).

This is USFDA, ANVISA, and MCC approved company. Zenotech is a group of Ranbaxy which is collaborated with Daiichi Sankyo, Japan.

Present Company: Indian Immunologicals Ltd (Central Govt) as RA Executive from (June-2014 to till date )

JOB PROFILE:

Preparation and submission of dossiers ANDA’s CTD formats to regulatory authorities.

Compilation & Preparation of ACTD for Asian countries like Cambodia, Vietnam.

Preparation, compilation &registration of documents that include Administrative Technical.

Preparation of dossiers CMC modules in CTD formats to regulatory authorities.

Compilation & Preparation of dossiers as per ICH guidelines.

Review of documents such as BMR’s, BPR’s, Raw Material/Finished Product Specifications, PDR’S, Annual Product Reports, stability protocols & specifications, Stability data and Validation reports for regulatory compliance.

Liaison with various departments like Formulation R&D, Analytical R&D, QC, QA, and Production.

Monitoring of Startup Check list, Carrying out line clearance at all stages of operations as per sop/BPCR.

Documentation:

Involved in QA documentation, issuance and retrieval of critical documents like BMR’s, BPR’s, validation protocols etc.

Preparation of SOP’s and the relevant log sheets.

Review of stability data and stability protocols.

Annual product Quality Review:

Preparation of trends for all chemical and microbiological parameters for all the products manufactured during the annual year.

Compilation of the data including all the details pertaining to the product and the relevant deviations, non- conformances, market complaints, etc., occurred, if any. Working as a member of Quality Management system team.

Process validation:

Preparation, monitoring and review of process validation related activities.

Co-ordination with IPQA & Production personnel for smooth going of process validation activities.

Handling of deviations / Incidents occurred during the process validation activities.

Vendor Qualification:

Initiation of Vendor Qualification in consultation with Purchase department and Head – QA. Collection of data from vendor, assessment of vendor qualification questionnaires, sending samples to QC department and evaluation of samples results

Initiation, handling, review, and assessment, closing of QMS activities which includes change controls, deviations/incidents, CAPA.

Monitoring of GMP records & verification.

Performing routine in process Q.A activities in Dispensing, compounding, Optical inspection, Labeling, Packing & Reconciliation of stage wise yield in Packing.

Implementation of systems and procedures as per written in standard operating procedures.

Conducting manual validation for operators.

Online monitoring of activities and documentation.

Performing optical inspection (spot checks) on inspected good sterile containers.

Verifying packed quantity of sterile containers through FGTR/FGTN and certifying to transfer to warehouse under quarantine.

EDUCATIONAL QUALIFICATION

M.Pharmacy: In Pharmaceutical Chemistry, Vels University, Chennai with 70%

B.Pharmacy : From Rajiv Gandhi University, Bangalore with 71%

D.Pharmacy : From State Board of Technical Education & Training, A.P with 80%

Intermediate : From SR Junior College, Khammam, A.P with 84%

S.S.C : From Mont Fort High School, Khammam, A.P with 76%

STRENGTHS

Self Confidence and Positive thinking

Leading the team

Management skills

Hard working & Communication skills.

Willing to learn new things.

Time management

IT KNOWLEDGE:

Operating Systems : Windows 7, XP professional

Packages : MS – OFFICE 2007, 2010

CONTACT DETAILS

Name : Ch.Laxma Reddy

Father’s Name : Ch.Pratap Reddy

Date of Birth : April 09, 1987

Languages known : Telugu, English, Kannada and Hindi

Marital Status : Married

Address : SRT-1043, Sanath nagar, Hyderabad.

DECLARATION

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

Place: Hyderabad

Date: Ch.Laxma Reddy



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