V.VENKATESWARLU, S/o V.Pulla Reddy. HOD-QA & QC

Hindustan foods limited.Hindustan Unilever company,Hyderabad.

E-mail: adpyq4@r.postjobfree.com. +91-800******* & alternative:879*******

PROFILE SUMMARY

A decisive, results-driven quality Assurance professional with over 15.11 Years of proven success in pharmaceutical /Biopharmaceutical/ Food industry in developing, implementing and maintaining compliant quality standards.

Corporate Quality, Operations Quality, Audit and compliance, Supplier Quality, Quality systems, Validations (Process, Equipment), Compliance Remediation, Inspection readiness and handling, Risk assessment, Documentation issuance & control, Training management, Investigations, Market complaints, ESOP System and Animal testing. ( Invivo and Invitro studies.)

ASSETS & SKILLS:

Inheritance of Quality compliance, sustainability and continuous improvement

Involved in all phases of pharmaceutical manufacturing –Design and implementation of quality systems, pre-approval inspections, commercial manufacturing and post -approval inspections.

Ability to understand regulatory guidelines, interpret requirements and design policies and procedures.

Ability to conduct and write investigations.

Peer review of quality documents

Strong interpersonal, communication, managerial and organization skills.

GLP compliance.

Invivo and Invitro studies.

Education

M.Sc. Biochemistry from Andhra University, Vizag in 2004.

Work experience

Hindustan foods limited, Hyderabad.

HOD QA & QC from 30-Apr-2021 to 18.10.2021.

GSK Bio-Pharmaceuticals, Ankleshwar, Gujarat. (CBVPL a BBIL company)

Assistant Manager QA from 27-Nov-2017 to 23-04-2021.

PFIZER Aurangabad, Maharashtra.

Executive from 04-April-2016 to 20-Nov-2017

AUROBINDO PHARMA LIMITED UNIT-06 Hyderabad.

Trainee chemist to Senior Executive from 27-Oct-2005 to 25-Mar-2016.

Awards and Recognitions

Awarded “PGS Recognition certificate “from Pfizer Global supply on successfully achievement of meeting the timelines for quality management system documents and supporting to the other production plant at Aurangabad site in their QMS activities. (2016 Q4 Mission Award.)

Computer Skills

MS-office.

ROLES AND RESPONSIBILITIES HANDLED

Quality management activities

Events monitoring

Change control management

Deviations management

CAPA Management

Documentation and Data integrity management

Training information management system

Document management system

Market compliant system/Product technical compliance system.

Documents and Drawings

Provide user requirement specifications (URS) and impact assessment; prepare DQ, IQ, OQ and PQ qualification for process equipments.

Designing and implementing strategies for building team effectiveness by promoting a spirit of cooperation between team members.

Sterile Assurance validations

Responsible for preparation of study protocols for cleaning validation for sterile formulation activities.

Restart protocols for Manufacturing, packaging & Quality control activities on chemical analysis, IPC analysis, microbial analysis and Animals testing analysis.

Responsible for conducting IPC lab, ELISA lab, Microbiology and Animal testing laboratory compliance.

Responsible for the audit compliance sterile formulation & API activities.

Responsible for review of process simulation activities.

Responsible for review of process and drying validation protocol and its approval.

Responsible for reviewing of the environmental monitoring program in critical and controlled areas.

Responsible for the conducting and establishment of dirty and clean equipment hold time studies and establishment of the hold time studies for sterilisable items like porous loads, metal loads and sterile manufacturing, sterile pipe connections and assembling accessories.

Review of validation master plan.

Involved in the commissioning activities of various equipment’s.

Handling Validation & Qualification activities like cleaning validation, process validation, and HVAC and equipment’s..

Safety/EHS

Perform the PHA for the existing and new facility by using HAZOP.

Perform the Quality risk assessment.

Software tools

SAP-system applications and data for processing.

PLS- For learning of standard operating procedures, protocols, other technical requirements required for operation and maintenance of manufacturing equipments & Qualifications of equipments. (PLS-Pfizer learning system)

PDOCS-Paperless documentation system for development, generation, review, approval, implementation, retention and obsolete of documents. (Pfizer document system)

Pfizer BT on demand- For Learning.

Pfizer HR on demand- For recruitment, resignation, personal information and maintenance of the employee salary.

Web EX portal for communication to the other sites of Pfizer for training and learning.

GSK Electronic SOP life cycle management.

GSK SAP Management system.

Current address

C/O, Prabhakar reddy H.NO-4-60/3, sai nilayam, Saibaba nagar colony, shad nagar, Rangareddy district, Telangana state-509216.

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