Summary
Overview
Work History
Skills
Professionalexperience
Instrumentshandled
Trainings
Educationalqualifications
Careersnapshot
Personal Information
Languages
Timeline
Hi, I’m

SSS Appalaraju Konakalla

Bengaluru
SSS Appalaraju Konakalla

Summary

Proven skills in Review, planning and scheduling in the team. Rich problem-solving capability. Ability to lead team under pressure situations to meet deadlines. Sound communication skills & Rich presentation skills Excellent knowledge on Calibration & Trouble shooting of instruments handled. Having good practical & theoretical knowledge on chromatographic techniques and chemical analysis. Knowledge on Laboratory safety. Good knowledge on Stability studies, audit and compliance.

Overview

14
years of professional experience

Work History

Cipla Pvt. Ltd

Deputy manager
12.2014 - Current

Job overview

  • Responsible for QC planning activities
  • Handling QC projects and implementing robust quality metrics
  • Identifying and implementing the cost improvement projects
  • Monitoring of batch release (Raw materials, Packaging materials, Intermediates, and API) and maintaining SLA to meet the organization's goals
  • Responsible for analyzing the RCA for SLA misses and implementation of effective CAPA to meet SLA
  • Responsible for stability testing on time and reducing the TAT for stability sample release
  • Responsible for the reduction in instrument breakdown
  • Responsible for idea generation and implementation
  • Monitoring and improving analyst productivity
  • Responsible for sampling and batch release with the collaboration of CFT
  • Handling of Non-conformances such as OOS, OOT, Deviations, and Incidents and reduction of nonconformances
  • Imparting training to enhance productivity
  • Handling of audits and compliance
  • Planning of sampling activities, skip testing and analysis
  • Management of retention samples through LIMS
  • Following good laboratory practices and good documentation practices
  • Responsible for monitoring the equipment log books and records
  • Preparation of test data sheets as per specifications and Certificate of Analysis
  • Carrying out IQ, OQ, PQ for the instruments, Software validations and preparation of Qualification protocols
  • Preparation of Standard operating procedures, instrument operating procedures and equipment operating procedures
  • Responsible for implementation of SOP’s, instrument operating procedures and equipment operating procedures
  • Responsible for review of analytical documents, calibration reports and calibration master schedule
  • Responsible for activities using SAP and LIMS
  • Responsible for monitoring of stability studies.

Apotex Pharma Chem India PVT Ltd

Associate
05.2014 - 12.2014

Job overview

  • Responsible for Stability samples analysis as per the stability schedule
  • Responsible for both chemical and instrumental analysis
  • Worked on non-conformances such as OOS, OOT, and LIR
  • Handled the instruments such as KF- Auto titrator, HPLC, GC, IR, UV, XRPD, PSD.

Dr Reddy’s Laboratories Ltd

Senior Executive
09.2011 - 05.2014

Job overview

  • Worked in in-process, stability, and finished team
  • Responsible for analysis and review, and release of in-process & intermediates
  • Monitoring of TAT through SAP
  • Operation and calibration of instruments such as KF- auto titrator, Halogen moisture analyzer, pH meter, Conductivity, IR, HPLC, GC
  • Handled the non-conformances such as OOS, OOT, and incidences.

Aurobindo pharma Ltd. (Formulations)

Trainee Chemist
09.2010 - 09.2011

Job overview

  • Responsible for analysis of Raw materials, Packing materials & finished products (LIMS)
  • Responsible for analysis of both Instrumental & chemical analysis
  • Responsible for daily calibrations of Analytical balance, PH meter & KF standardizations.

Skills

  • QC planning activities
  • Extensive experience in pharmaceutical quality control
  • Expertise in both instrumental and chemical analysis
  • Strong problem-solving capabilities and ability to lead teams
  • Cost reduction through skip tests and reduced testing
  • Handling non-conformances and compliance with regulatory standards
  • Monitoring of Stability studies
  • Knowledge of SAP and LIMS
  • Participation in USFDA, TGA, and other regulatory audits
  • Excellent communication and presentation skills
  • Identifying RCA and Implementation of effective CAPA
  • Problem-solving
  • Team leadership
  • Laboratory safety
  • CIPDOX
  • TRACKWISE
  • LMS
  • EMPOWER
  • CHROMELEON
  • Quality Management Systems
  • Specification Review
  • Team Collaboration
  • Knowledge of auditing systems

Professionalexperience

  • Cipla Pvt. Ltd, December 2014 to till date, Deputy manager, Quality Control, Section Head – Planner, Batch release and Stability studies
  • Apotex Pharma Chem India PVT Ltd, May 2014 to December 2014, Associate, Quality Control, Analyst- Stability studies
  • Dr Reddy’s Laboratories Ltd, Sep 2011 to May 2014, Senior Executive, Quality Control, Analyst
  • Aurobindo pharma Ltd. (Formulations), Sep 2010 to Sep 2011, Trainee Chemist, Quality Control, Analyst

Instrumentshandled

HPLC& GC (Waters, Shimadzu and Agilent with Empower software and Chromeleon software). FT-IR(Perkin-Elmer) Melting Range by MR Apparatus (Digital and Manual) UV Spectrophotometer with UV probe software. KF Titrator (Metrohm) and Auto titrator (Tiamo software) PH & Conductometer (Metrohm) Halogen & IR Moisture Analyzer Disintegration Apparatus Bulk Density apparatus Specific optical rotation (Rudolph)

Trainings

Attended various seminars on Chromatography, Spectroscopy, Water content, Potentiometry by different manufacturers and Schedule M.

Educationalqualifications

  • Executive MBA (Operations Management), Dayanand Sagar University, Bangalore
  • M.Sc. (Organic Chemistry), M.V.R (P.G) College, Gajuwaka, Visakhapatnam, 74.90%
  • B.Sc. (MPC), DNR College, Bhimavaram, West Godavari, 80.05%
  • Intermediate (MPC), Dr SRK & AKR CO-OP Jr College, Nallajarla, West Godavari, 88.70%
  • SSC (Matriculation), ZP High School, Prakasarao Palem, West Godavari, 86.00%

Careersnapshot

Having 13+ years of rich experience in the pharmaceutical quality department as an analyst, team lead, and planner. Proven skills in reviewing, planning, and scheduling QC activities. Expertise in identifying RCA for SLA misses and implementation of effective CAPA to meet the business targets. Rich problem-solving capability. Ability to lead a team under pressure situations to meet deadlines. Identifying the gaps/ improvement areas and reducing cycle time by implementing a robust process/technique. Having good experience in handling non-conformances. Expertise in cost reduction by implementing skip tests and reduced testing. Sound communication skills and rich presentation skills Excellent knowledge of Calibration and troubleshooting of analytical instruments. Having good practical & theoretical knowledge of chromatographic techniques and chemical analysis. Knowledge of Lab safety. Expertise in stability studies. Hands-on experience in SAP and LIMS. Actively participated in audits like USFDA, TGA, internal audits, and customer audits.

Personal Information

  • Date of Birth: 12/27/86
  • Marital Status: Married

Languages

English, Telugu, Kannada, Hindi

Timeline

Deputy manager

Cipla Pvt. Ltd
12.2014 - Current

Associate

Apotex Pharma Chem India PVT Ltd
05.2014 - 12.2014

Senior Executive

Dr Reddy’s Laboratories Ltd
09.2011 - 05.2014

Trainee Chemist

Aurobindo pharma Ltd. (Formulations)
09.2010 - 09.2011
SSS Appalaraju Konakalla