CURRICULUM VITAE

CHIDUMULA LAXMA REDDY E-mail: adjgqn@r.postjobfree.com Regulatory affairs & Quality Assurance Mobile: +91-766*******

OBJECTIVE:

To pursue a challenging career in the field of Pharmaceuticals and Biologicals 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:

Insightful experience of 7.6 years in the Pharmaceutical & Biotechnological Industry, I have worked across various functional groups of Regulatory affairs & Quality Assurance department in esteemed organizations.

Currently working with Aurobindo Pharma Limited as Senior Executive in Regulatory affairs department & Quality Assurance from November-2016 to till date.

Currently working with Indian Immunologicals Limited as Executive in Regulatory affairs department & Quality Assurance department from June 2014 to Nov-2016.

Previously working with Zenotech Laboratories Limited as Executive in Regulatory affairs department & Quality Assurance department from Dec-2013 to May-2014. Zenotech Laboratories Limited is USFDA approved manufacturing facility and engaged in manufacture of sterile injectables (Oncology and General Injectables) & Biotechnology products.

From May-2013 to November-2013 worked with Gland Pharma Limited as Officer in Quality Assurance department. Gland Pharma Limited which is also a sterile injectable plant approved by USFDA, MHRA, ANIVISA, TGA.

JOB PROFILE:

JOB RESPONSIBILITIES AT AUROBINDO PHARMA LIMITED:

To review all the documentation related to regulatory submission (Batch records) and submits to regulatory department.

Submission & Review of Annual report information which includes distribution data, CMC changes, stability data, Field alert report filed information to the regulatory review team.

Sound Knowledge on Preparation of dossier (Module 3, Module 2.3 and relevant Module 1 documentation).

Submission & Review of documents to be placed in section 3.2.p.3.

Follow up for queries related to dossiers. To keep track of pending Queries from RA of various countries and do time bound follow-up.

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

Ensuring quality, timely preparation of core submission dossiers & registration of products.

Regulatory CMC (Module 3) change control co-ordination and management including Impact Assessment.

Compilation and review of Stability study report of finished product.

Compilation & Preparation of Dossiers as per ICH guidelines.

Review & submission of Exhibit batch production records.

JOB RESPONSIBILITIES AT INDIAN IMMUNOLOGICALS LIMITED & ZENOTECH LABORATORIES LIMITED:

Preparation of dossier (Module 3, Module 2.3 and relevant Module 1 documentation).

Preparing regulatory dossiers in CTD formats for International submission.

Compilation & preparation of A-CTD for Asian countries like Cambodia, Vietnam.

Compilation & preparation of Dossiers for countries such as Mauritius, Myanmar.

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

Ensure compilation and internal review of regulatory dossiers as per schedule and their timely submissions.

Evaluation of CMC changes and identification of supporting documentation required to support relevant variation packages

Providing strategic inputs to the client for CMC related activities.

Compilation & Preparation of Dossiers as per ICH guidelines.

Compilation and review of Stability study report of finished product.

Coordination in preparation of Raw Material Specification and Finished Product Specification, Certificate of Analysis of Raw Material and Finished Product, Stability data of Finished Product.

Checking the Product Designs/Labelling and ensuring they comply to regulatory guidelines.

Follow up for queries related to dossiers. To keep track of pending Queries from RA of various countries and do time bound follow-up.

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

Calculation of Maximum allowable carry over (MACO) in cleaning validation.

Preparation, monitoring and review of cleaning validation related activities.

Assisting for validation of Equipment’s like Tunnel, steam sterilizer, HVAC.

Stability study: Preparation of the Protocols as per stability guidelines. Reviewing the stored samples analysis reports and retention of the data.

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

JOB RESPONSIBILITIES AT GLAND PHARMA LIMITED:

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.

Compilation of the data including all the details pertaining to the product and the relevant deviations, non- conformances, market complaints occurred, if any.

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.

Giving line clearance for each processing stage, Performing In - Process checking during production activity. Ensure for online completion and compilation of Shop floor documentation.

Documentation: Preparation, Review of SOP’s and validations protocols & Archival of the Authorized documents.

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

Educational Qualification:

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

B-Pharmacy: From Rajiv Gandhi University, Bangalore with 70%

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%

Languages Known: Telugu, English, Hindi and Kannada.

Contact details:

Name : Ch. Laxma Reddy

Father’s Name : Ch. Pratap Reddy

Date of Birth : April 09, 1986

Marital Status : Married

Address : Flat No:G2, Veni Nilayam, KPHB 9th Phase, Hyderabad.

Declaration:

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

Date: Ch. LaxmaReddy

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