PARDHASARADHI RAJANA
Hyderabad
Summary
I wish to introduce myself as "Sr. Manager" in Quality Assurance Cura TeQ Biologics (Subsidiary of Aurobindo Biologics) in Hyderabad. I have 16 years of experience in the field of Bio Pharmaceutical (Biosimilars, Vaccines & Cell and Gene Therapy) and Pharmaceuticals. I aspire to associate myself with a dynamic Organization like yours in a pursuit to learn as well as contribute to the best of my knowledge, ability, and Skill. I strongly believe that an opportunity I will be able to successfully deliver my Responsibilities befitting the same. I am determined to make a career in your organization and request you to give me an opportunity to prove myself in this esteemed organization. Experienced in hiring and developing individual team members.
Over the past 16 years, I have been in the several roles in Quality Assurance & Quality control in Sterile Injectable, Vaccines, Cell Gene Therapy and Biosimilar's. Versatile Senior Manager specializing in Quality Assurance and skilled at planning, implementing and overseeing key improvements to drive business growth and efficiency. History of cultivating an open culture with free exchange of information. Pursuing new professional challenges with a growth-oriented company. Versatile Senior Manager specializing in Quality Assurance and skilled at planning, implementing and overseeing key improvements to drive business growth and efficiency. Forward-thinking Senior Manager adept at managing teams of ten employees with three direct reports to accomplish challenging objectives. Imparts clear vision to guide cohesive, high-performing teams. Strong leader and problem-solver dedicated to streamlining operations to decrease costs and promote organizational efficiency. Uses independent decision-making skills and sound judgment to positively impact company success.
Overview
15
15
years of professional experience
Work History
Senior Manager
CuraTeQ Biologics An Aurobindo Pharma Company
01.2023 - Current
- Role in compliance: QA section lead looking after overall Quality Assurance activities including Analytical QA functions, batch release and GMP documents review and approvals, QMS, audit and compliance
- Develop and execute the strategy for the GMP/GDP Corporate Quality System
- Provide leadership and guidance to the QMS Process Owners community
- Experienced in manual as well as digital platforms of QMS i.e
- Track wise & Oracle-Agile etc
- Lead and optimize QMS governance including review and approvals of Quality Management Documents; Deviations, OOS, OOT, OOL, Lab Incidents, Investigations, QRM, CAPA, Change Control, Management notification, implementation of Global CAPA, etc
- Looking after Batch release, Stability Management, Reference standards, control samples, Method Validations, Method Transfers, review of study protocols and reports, etc
- Self-inspection coordinator and external inspection readiness for all regulatory, market, EU, USFDA, MHRA,TGA, EMA-EDQM, HEALTH CANADA,ANVISA,INVIMA, WHO and DCGI & CDSCO and company standards
- Role in Management of Quality Assurance: Timely review and release the batch, review and supervise the stability protocol
- Review of Raw material and packing materials specifications and MOA's
- Release and approval of the Raw material in ERP
- Involved in preparation, review and revision of major quality system SOP
- Also review the cross functional departments SOP, EOP, STPs, Specifications, Study protocols, Investigation plans, etc
- Periodic review of QMS trends, product annual quality review, Environmental Monitoring data assessment, etc
- Supports inspection and audit preparations
- Develops strategies for assigned Quality Process to be fit for purpose, including continuous improvements and ensure a state of inspection readiness
- Lead improvement initiatives and foster a change management culture
- Timely escalations for the major gaps and non-compliance impacting product quality and system to the head quality assurance
- Ensures the activities in accordance with GLP and ALCOA to assures data reliability and compliances (Data integrity)
- To review as well as act as work leader for Change controls related to microbiology and analytical and equipment pertaining to Quality control areas
- Ensures compliance of established analytical and microbiology laboratory operational compliance with global quality and current regulatory guidelines.
- Enhanced product quality by implementing rigorous testing protocols and identifying areas for improvement.
Sr. Scientist
Aurigene Oncology
01.2022 - 01.2023
- Lead for Quality control Microbiology department
- Planning and ensuring timely releases of Microbiology test samples
- Responsible for Microbiology operations like providing resources, trainings, monitoring of compliance, coordination with cross functional departments for regular activities
- To train the team in necessary procedure and clarify the standard operating procedures if any deviations are observed
- Monitoring method transfer and method verification activities.
Manager
Biological E Limited
08.2015 - 12.2021
- Handling of four green field projects
- Involved in the review & execution of Protocols, Reports related to Qualifications of various equipment, Utilities & Facility
- Qualification of microbiology lab with equipment's and instruments
- Preparation of SOP's, STP's, Protocols and Summary reports for Validations as per regulatory guidelines
- Participate in intra- and inter- departmental meetings/ discussions for fulfilling the objectives
- Monitoring GLP activities like Calibrations, Qualification of instruments and management of working standard & referenced standards etc
- Component preparation of various autoclave loads that are sterilized in Fedigari autoclave
- Responsible for Microbiology operations like providing resources, trainings, monitoring of compliance, coordination with cross functional departments for regular activities.
Sr. Executive
Hospira Healthcare India Pvt.Ltd
03.2010 - 08.2015
- Handling the Sterility Method validations for various regulatory markets (US, JP, TGA, and ANVISA & MHRA)
- Media fill validations
- Performance verification of equipment's like Steam sterilizers, Laminar Air flow stations and incubators are validated as per the predetermined guidelines
- Handling of Bacterial Endotoxin Test (BET) by Gel-clot method for finished product, raw material, stability samples
- Microbiological method validations of Sterility, BET and MLT
- Handling of cultures-Sub culturing and culture suspension preparation
- Establishment of hold studies and the periodic microbial monitoring of all the sterilizable and non-sterilizable items involved in the aseptic process
- Particulate matter test by LBPC for finished samples and raw materials
- Prequalification of biological indicators and Bio balls
- Media preparation, inventory, and qualification by Growth Promotion Test.
Executive
Orchid Pharmaceuticals LTD
06.2009 - 03.2010
- Water sampling, testing trending of results
- Environmental monitoring sampling resulting and Trending of results
- General lab instruments monitoring
- EM & water isolates identification (Species level by VYTEK 2 COMPACT).
Education
Master's in biotechnology -
Periyar University
Salem, Tamil Nadu01.2008
Bachelors in Botany, Zoology & Chemistry -
Andhra University
Visakhapatnam, Andhra Pradesh01.2006
Skills
- Deep knowledge and experience with Quality Systems in the Biopharmaceutical industry
- Strategic thinker with drive for business continuous improvement and customer focused
- Handling of QMS tools for events, change controls, OOS, OOL, Deviation & CAPA managements such as eQMS
- FMEA Risk Facilitator
- SOP's preparations, review, and approval in eDMS system
- Review of air flow visualization studies and identification locations for EM
- Well Expertise in Area Qualification (Viable & Nonviable)
- Sound knowledge in microbial method suitability's and method validations
- Specialized in aseptic practices and techniques in clean rooms
- Expertise in cleaning and disinfection programme
- Selection of Disinfectant, Qualification and Validation
- Preparation of gap assessments with respect to updated current regulatory requirements
- Expertise in QRM and PQS principles and development of CCS in the organization
- Quality Risk Assessment
- Documentation Review
- ISO Standards
- Defect tracking
- Quality Management Systems
- Corrective Action Planning
- Internal Auditing
- CAPA Management
- Change Control Management
- Validation Protocols
- Quality Assurance Auditing
- Internal Audits
Accomplishments
- Awarded as BE STAR for qualification of HVAC system and UTILITIES at SEZ Non live and live facility.
- SME in cycle development, cycle validation of isolators, validations of Autoclaves.
- Awarded for Closing of 06 MicrobiologyMethod validation CAPAs without any Deviations in the year of 2014.
- Certified trainer on good documentation practices and Data integrity.
- Awarded as CI Specialist for simplification of documentation and media preparation tasks by introducing automatic instruments and equipment in 2013 at Hospira Health Care India Pvt Ltd.
- Resolved product issue through consumer testing.
SOFTWARES HANDLED
TRACKWISE
AGILE
LIMS-CALIBER&LABWARE
MODA-EM - LONZA
ATACHI-eTMS
ATACHI-eDMS
ELN LOGBOOK
AUDITS
USFDA
EMA
MHRA
TGA
HEALTH CANADA
ANVISA
WHO
DCGI&CDSCO
SAHPRA
Languages
English
Bilingual or Proficient (C2)
Telugu
Bilingual or Proficient (C2)
Hindi
Intermediate (B1)
Tamil
Personal Information
- Father's Name: KALYANAM
- Date of Birth: 05/03/1985
- Marital Status: Married
Timeline
Senior Manager
CuraTeQ Biologics An Aurobindo Pharma Company
01.2023 - Current
Sr. Scientist
Aurigene Oncology
01.2022 - 01.2023
Manager
Biological E Limited
08.2015 - 12.2021
Sr. Executive
Hospira Healthcare India Pvt.Ltd
03.2010 - 08.2015
Executive
Orchid Pharmaceuticals LTD
06.2009 - 03.2010
Master's in biotechnology -
Periyar University
Bachelors in Botany, Zoology & Chemistry -
Andhra University
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