K. BHASKAR REDDY
KHONI PALLAVA
Summary
- Track record of directing 6+ successful USFDA Inspections. Currently led successfully USFDA Inspection at Enaltec Labs – for API Manufacturing Plant in March 2025 - previously led successful USFDA inspections at Enaltec labs - 1st for Analytical Method Validation Center (testing laboratory) in Feb’19 and 2nd for API Manufacturing Plant in Jul’19.
- Performance-driven professional with over 2 decades of rich & extensive experience in Quality Assurance, Quality Control, Audit, Compliance Management and People Management.
- Led productive cross-functional team using interactive and motivational leadership that spurs people to willingly give excellent results for Operational Releases and Compliance.
- Skilled in streamlining the Stability Studies, Process Validations, Cleaning Validations, Method Validation, Equipment / Instrument Qualification, Standards Qualification, Software Validation program activity for the site.
- Swiftly completed projects like Oncology APIs, and General APIs with cross-functional skills and ensuring on-time deliverables within preset parameters.
- Steered efforts in initiation of safety culture at workplace with aim of zero harm.
- Expertise in preparing and sending ASMF/ COS/ DMF related Responses to various authorities and to customers for approval.
- Excels in regulatory Compliance support to the manufacturing site.
- Facilitated Investigations of Out Of Specifications (OOS), Out Of Trends (OOT), Deviations, Incidents, Change Control & Market Complaints and ensuring the investigations are properly closed with an effective CAPA.
- Compliance Preparedness - Pivotal in identifying underlying risks, deficiencies, and opportunities at forefront with proficiency in auditing the new facilities of the company and preparing the GAP analysis reports with recommendations.
- A strategist & implementer with recognized proficiency in business to accomplish corporate plans and goals.
Overview
26
26
years of professional experience
3
3
Languages
Work History
General Manager Quality Assurance
Enaltec Labs Private Limited
07.2018 - Current
- Developing & executing high level Quality Assurance strategies, Quality Control, making high-stake decisions and overcoming complex business challenges using experience-backed judgment, strong work ethics and irreproachable integrity
- Creating & sustaining a dynamic environment that fosters the development opportunities and motivates the high performance amongst the team members
- Collaborating with stakeholders while keeping them informed of progress and issues in order to manage expectations on all requirements and deliverables
- Heading several TPM activities in order to increase productivity, quality, save cost, fast delivery; proficient in documentation practices, chromatographic practices, laboratory software's as like eLIMS, EDMS etc.
- Directing regulatory affairs department for preparation of ASMFs/ COSs/ DMFs in CTD/ eCTD (Citrix) format in Regulated market (i.e. EMA, FDA, Canada, CEPs, and so on) as well as in the Rest of the World for timely submissions as per the Customers and Organization requirements
- Managing review and Finalization of Route of synthesis, starting materials manufacturers for the API/Drug substance/projects as per the Regulatory requirements
- Reviewing of documents required in preparation of ASMF/ COS/ DMF (i.e. Data received from Manufacturing unit, R&D, QC, ADL, QA
- Leading FDA inspections and responses to inspectional observations effectively to maintain cGMP compliance at site
Quality Head
AR Life Sciences Pvt. Limited
02.2012 - 07.2018
Asst. General Manager – QA
MANTENA LABORATORIES LIMITED
11.2010 - 12.2011
Ø Responsible for Overall Quality Assurance activities (Unit 1 & 2).
Ø Responsible for all Equipments, Utilities, Facilities & Systems qualification & validation.
Ø Responsible for Preparation of Open part DMF’s.
Ø Responsible for Process & Cleaning Validation.
Ø Responsible for the Customer & Regulatory Audits.
Ø Responsible for Change controls, Deviations & OOS.
Ø Responsible for training activities related to SOPs, Regulatory Guidelines & Validations.
Ø Responsible for review & execution of activities related to SOPs.
Ø Responsible for Vendor Audits.
Ø Faced the Audit WHO - GMP.
Manager - QA
Malladi Drugs & Pharmaceuticals Limited
03.2009 - 11.2010
Assistant Manager - QA, Audit & Compliance
Micro Labs Limited
08.2007 - 03.2009
Management Staff
Cipla Limited
11.2005 - 08.2007
Senior Executive
Dr. Reddy's Laboratories Limited
08.1999 - 11.2005
Education
Master of Science - Chemistry
Vikas National Open College
Bachelor of Science - Chemistry
Osamania University
Hyderabad, Andhra PradeshSkills
- Strategic Planning
- Quality Assurance & Quality Control
- Audit & Compliance Management
- Total Quality Management
- Project Management
- New Plant Set-up
- Stakeholder Management
- Documentation
- Validation
- Cross-functional Coordination
- Technology Transfer
- Performance Evaluation
- Training & Knowledge Sharing
- Team Building & Leadership
Personal Information
Date of Birth: 06/09/77
Notable Accomplishments
- Facilitated FDA preparedness activities; and implemented appropriate CAPAs on the identified areas as continual improvement and successfully led USFDA inspections along with response/communications to FDA for inspectional observations
- Directed +15 Health Authority inspections like USFDA, WHO, EDQM, MHRA, TGA, and so on; 300+ customer audits
- Played a key role in initiating efforts & reducing deviations by 70% in stability study for stipulated time frame analysis, reduced lab events & errors/unconfirmed OOS by 40% and increased the occupancy/utilization of Equipment's up to 75%
- Quality expenses by 30% and improving the system of inventory in QC consumption of solvents in laboratory and production
- Acknowledged for executing Commissioning & Qualification of new production block, purified water system, quality control laboratory for API manufacturing and Technology transfers accordingly
- Track record of reducing SOPs by merging the same contents and different SOPs in single SOP; revised calibration procedures to cover the operational ranges
- Instituted timely resolution of encountered non-compliances and implementation of timely action plan as preventive measure
- Steered efforts in evaluating changes related to Product, Process, Equipment and conducting impact analysis for the potential changes
- Adjudged for increasing the productivity & service level for operational releases; registered > 95% RM and intermediates within 3 days from date of receipt, 4 days for finished API without microbial examination and 7 days with microbial examination
- Bagged Awards in various companies for individual and team for reduction in quality expenses & lab in compliance activities
Timeline
General Manager Quality Assurance
Enaltec Labs Private Limited
07.2018 - Current
Quality Head
AR Life Sciences Pvt. Limited
02.2012 - 07.2018
Asst. General Manager – QA
MANTENA LABORATORIES LIMITED
11.2010 - 12.2011
Manager - QA
Malladi Drugs & Pharmaceuticals Limited
03.2009 - 11.2010
Assistant Manager - QA, Audit & Compliance
Micro Labs Limited
08.2007 - 03.2009
Management Staff
Cipla Limited
11.2005 - 08.2007
Senior Executive
Dr. Reddy's Laboratories Limited
08.1999 - 11.2005
Bachelor of Science - Chemistry
Osamania University
Master of Science - Chemistry
Vikas National Open College
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