Penchalaiah Salava
Quality Control Assistant Manager
About
An astute professional with over 16.2 years of experience and having professional experience in Quality Control analytical techniques, Handling of Investigations. Having expertise in performing all day to day operational activities in the quality control laboratory. Strong interpersonal, writing, and multi-tasking skills with the ability to work in a team for meeting compliance with good laboratory practices & ALCOA.
Complete Quality
Control aspects like review of Stability, RM, Inprocess and finished product reports. Experienced in Handling of Team with Team size 14 members.
Experience
Assistant Manager, Quality Control - APOTEX RESEARCH PVT LTD - Bangalore
(2015-04)
Working as Quality Control ASSISTANT MANAGER, skilled in All analytical instruments in Laboratory, QMS & Laboratory controls to maintain compliance to standards. A Quality Management Professional with 16.2 years of experience in Quality Control Department in Pharmaceutical Industry (Formulations).
- Planning and Handling of Team with Team size 14 members
- QMS related work (OOS / OOT / Deviation / Laboratory incidents)
- Analytical data review
- Ensuring Timely completion of Laboratory investigations with good write up skills and Scientific Rationales
- Conducting investigation for OOS/OOT/Anomalous results to identify assignable cause wherever applicable
- Co ordinating with Quality Control Cross functional teams: Manufacturing and QA teams for smooth functioning of the department
- Working in 6S Environment
- Always maintaining TAT Within 10 Days
- Conducting Gemba walk on daily basis
- Familiar with GLP and GDP practices
- Familiar with QMS: Laboratory Incidents, Deviations, OOS and Change controls
- Ability to work as an individual and in team, confident in serving the best results in a goal oriented job
- Maintaining Safety and Quality while doing any activity in the Laboratory
- Attending daily meetings to know the priority and planning accordingly
- Conducting awareness training on Investigations to all the Analysts
- Experienced to achieve paperless environment by using software's like Empower-3, LABWARE LIMS
- Responsible for Execution and planning of Semi-finished product and Stability samples day to day analysis activities and reviewing of the analytical documents
- Assigning work to Analysts on priority basis through Lims
- Arranging resources to the Analysts
- Handling of Investigations on OOS, OOT and Anomalous results
- Handling of Incidents and Deviations
- Ensuring the calibration of instruments as per schedule
- Issuing samples to the Analysts
- Maintenance of Reference standards and working standards
- Adherence of the records for compliance with SOPs/STPs
- Maintenance of lab, equipment's as per GMP/GLP
- Maintaining reconciliation and Dispose of samples in LIMS and Physically
- Consumption of Chemicals, Working Standards and Reference Standards
- Preparation of Templates, Specifications, COA and SOP, Stability summary reports and Protocols
Quality Control Executive - MICRO LABS LIMITED ML-14 - Bangalore
(2012-02 - 2015-03)
Quality Control Officer - MEDREICH LIMITED UNIT-III - Bangalore
(2008-10 - 2010-08)
Education
Master Degree - Micro Biology - SV University (2006 - 2008)
Bachelor Degree - B.Sc - SV University (2002 - 2005)
Intermediate - Board of Secondary Education (1999 - 2001)
Secondary School Certificate - Andhra Pradesh (1998 - 1999)
