KRISHNA

CHAITANYA

MATURI

krishnachaitanya.maturi@

gmail.com

+91 – 903**-*****

+91 – 986**-*****

https://www.linkedin.com/

in/krishna-chaitanya-

b628273b

PROFESSIONAL

SUMMARY

Senior Quality Assurance

Executive capable of driving

and achieving the highest

production standards through

effective line management

technique.

Expertise in handling day to

day management of QA team

to support production in the

factory and compliance of all

quality policies.

EXPERIENCE (8+ YEARS IN PHARMA QA)

SPECIALIST QUALITY OPERATIONS • NOVARTIS HEALTHCARE PVT. LTD., HYDERABAD • AUG’19 – PRESENT

SENIOR EXECUTIVE – CQA • MICRO LABS LTD., BANGALORE • MAY’18 – JUL’19

EXECUTIVE – QA • AUROBINDO PHARMA LTD.,

VISAKHAPATNAM • FEB’15 – MAY’18

EXECUTIVE – CQA • MICRO LABS LTD., BANGALORE•

MAY’12 – JAN’15

Key Responsibilities Includes

Preparation of Standard Operating Procedures (SOPs) as per cGMP; Preparation & implementation of QA SOPs.

Determining, negotiating and agreeing on in-house quality procedures, standards and specifications.

Investigating and setting standards for quality and health and safety; Ensuring that manufacturing processes comply with standards at both national and international level. Acting as a catalyst for change and improvement in performance and quality; Introducing new product at facility; Directing objectives to maximize profitability; Recording, analyzing and monitoring performance etc.

Preparation & implementation of QA SOPs; Carry out self- inspection of cross functional department.

Ensure that all manufacturing processes are well documented and controlled through batch records, log books,

QMS Review

& Updation

Non - Compliance

Investigations

Vendor

Qualification

Excellent interpersonal &

communication skills. Results

driven, skilled leader focused

on achieving success and

increased mfg. productivity

through improvements in

operations, quality and safety.

OBJECTIVE

Seeking for a senior level

assignment in the QA domain

to hone my professional skills.

KEY – SKILLS

Technical

Expertise

Quality

Assurance

Planning &

Organizing

Team

Management

Caliber

QMS

SAP

MS – Office

Analytical

Problem

solving

Leadership

Manufacturing records are reviewed and GMP compliance confirmed before.

Monitor quality of the product at different stages of manufacturing i.e. Granulation, Compression & Coating area. Review and approve validation and qualification protocols and reports for processes and equipments.

Ensure the compliance of systems during manufacturing, packing and testing of products as per quality standards. Sampling the semi finish and finish products as per the batch record and process validation protocols. Collect and send the stability samples as per the requirement.

Ensure that customers complaint are handled: Analyzes customer complaint; Identifies trend and tendencies with respect to lot, product and type of complaint and determines the cause; Recommends changes based on investigation and trend analysis.

Review and Execution of schedules for Preventive

Maintenance, Calibration, Equipment and Process Validation as per Validation Master Plan.

Review of trend analysis reports for QMS system like Deviations, Incidents, Change controls and process investigations.

Review and investigation of OOS, CAPA, Deviations, Incidences and Change control document in order to compliance regulatory requirement.

Review & Approval of Quality Manual, Validation Master Plan

(VMP), Site Master File (SMF); Approval of Master Documents like Batch Manufacturing Record, Batch Packing Record Adherence to the service KPI’s and ensuring the service dashboard, order management framework and time sheet is always kept updated.

Implement processes and procedures to ensure continued improvement of product quality, safety, yield, reliability and quality system compliance.

Team Work

Time Mgmt.

Interpersonal

Comm.

AUDITS FACED

Report preparation for various internal, external and regulatory audit; Audit, Approve/Reject the vendor as per the cGMP requirements.

Hold and manage key accounts in workflow applications to ensure appropriate execution of service deliverables. Supporting Supplier Qualification Documents; External Supply Operations Quality Assurance Agreements for all the sites of Novartis.

Deliver the additional responsibilities as assigned by management; Upgrade knowledge in order to remain

proficient in the profession.

EDUCATION

MASTER OF PHARMACY • 2011 • ANDHRA UNIVERSITY

Completed my M. Pharm in Pharmaceutics from Sri Vasavi College, Tadepalligudem.

BACHELOR OF PHARMACY • 2009 • SRM UNIVERSITY

Completed my B. Pharm from SRM College of Pharmacy. PERSONAL DETAILS

D.O.B: November 28, 1987

Languages Known: English, Hindi & Telugu

Nationality: Indian

Krishna Chaitanya Maturi

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